- QULIPTA® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic
- Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities
- Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment
- AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine
NORTH CHICAGO, IL, USA I April 17, 2023 I AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA® (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine.1
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/
“Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie. “This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including QULIPTA as a preventive treatment for both episodic and chronic migraine; BOTOX® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY® (ubrogepant), an acute treatment for migraine attacks.”
QULIPTA’s expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.3 The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints.3 This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.4 These efficacy results are consistent with those in the ADVANCE episodic migraine trial.5
“The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill,” said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. “QULIPTA’s data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine.”
QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.6
“For years, I felt hopeless and struggled to find a treatment that not only reduced the number of migraine attacks but could also help reduce how often migraine impacted my daily activities like taking my kids to school or practices,” said Latoya Lawrence, a patient who has lived with migraine for more than 20 years. “After I started taking QULIPTA for my episodic migraine, I wasn’t as worried about when my next migraine attack might strike. I’m glad people living with chronic migraine now have a treatment option that has the potential to make a substantial impact on their lives.”
About the Phase 3 PROGRESS Clinical Trial
The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral QULIPTA 60mg once daily (QD) for the preventive treatment of chronic migraine.7 The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and greater than or equal to 15 headache days with greater than or equal to eight migraine days in the 28 days prior to randomization.7 The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo across a 12-week treatment period.7
Key secondary endpoints across the 12-week treatment period included: change from baseline in mean monthly headache days; change from baseline in mean monthly acute medication use days; proportion of participants with at least a 50% reduction in mean monthly migraine days; and change from baseline in Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. Key secondary endpoints also included change from baseline in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores. The AIM-D is a novel questionnaire designed to evaluate difficulty with performance of daily activities and physical impairment due to migraine.
About QULIPTA® (atogepant)
QULIPTA® is approved by the U.S. Food and Drug Administration (FDA) and is available in the United States for the preventive treatment of migraine in adults. QULIPTA is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is approved for the preventive treatment of chronic migraine.
Please see QULIPTA full Prescribing Information.
INDICATIONS
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older
- To treat increased muscle stiffness in people 2 years of age and older with spasticity
- To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older
BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.
It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits.
Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide.
About UBRELVY® (ubrogepant)
UBRELVY® is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.
What is UBRELVY® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.
Please see UBRELVY full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.
About Migraine and Chronic Migraine
Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.8 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.9-12
People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine.13 It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month,14 by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.14-16 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden.17-21 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.22-24
About AbbVie in Migraine
AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease.
- QULIPTA® (atogepant) is FDA-approved for the preventive treatment of migraine in adults. It is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. Since its initial approval for the preventive treatment of episodic migraine in September 2021, QULIPTA has been prescribed for nearly 200,000 patients.
- BOTOX® (onabotulinumtoxinA) is the first FDA-approved, preventive treatment for adult patients with chronic migraine. Since FDA approval in 2010, more than 5 million BOTOX® treatments given to more than 850,000 people living with chronic migraine.
- UBRELVY® (ubrogepant) is the first FDA-approved CGRP treatment for the acute treatment of migraine attacks in adults. Since its approval in December 2019, UBRELVY® has been prescribed for nearly 750,000 patients. It can be used in patients across the entire spectrum of migraine and regardless of other treatments (acute or preventive) they may be on or have tried.
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson’s disease, post-stroke spasticity, schizophrenia and others along with a robust pipeline.
We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- AbbVie. Data on File: ABVRRTI73750
- Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137?term=NCT03855137&draw=2&rank=1. Accessed on March 15, 2023.
- AbbVie. Data on File: ABVRRTI73750
- 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03777059.
- QULIPTA™ (atogepant) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID: PMC8904749.
- Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., & Katsarava, Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17.
- AbbVie. Data on File: ABVRRTI73750
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
- Buse DC, Manack A, Serrano DC, et al. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010;81:428-432.
- Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7) 563-578.
- Blumenfeld A, Varon S, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.
- Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31:837-850.
- Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO Study. Mayo Clin Proc. 2016;91:596-611.
- Buse DC, Powers SW, Gelfand AA, et al. Adolescent perspectives on the burden of a parent’s migraine: results from the CaMEO study. Headache. 2018;58:512-524.
- Buse DC, Murray S, Dumas PK, et al. Life with migraine, effect on relationships, career and finances, and overall health and well-being results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Cephalalgia. 2018;38(Suppl 1):9-10.
- Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey. Headache. 2016;56:306-322.
- Sanderson JC, Devine EB, Lipton RB, et al. Headache-related health resource utilization in chronic and episodic migraine across six countries. J Neurol Neurosurg Psychiatry. 2013;84:1309-1317.
- Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.
SOURCE: AbbVie
Post Views: 59
- QULIPTA® now the first and only oral CGRP receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic
- Expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities
- Approval based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment
- AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine
NORTH CHICAGO, IL, USA I April 17, 2023 I AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA® (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine.1
Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9120951-abbvie-qulipta-migraine/
“Since September 2021, QULIPTA has helped people living with episodic migraine prevent migraine attacks, reducing the daily burden of migraine. Now, those with the most challenging to treat chronic migraine can also rely on QULIPTA to significantly reduce their migraine days,” said Roopal Thakkar, senior vice president, chief medical officer, AbbVie. “This approval makes AbbVie the only company with three treatments across the spectrum of migraine, including QULIPTA as a preventive treatment for both episodic and chronic migraine; BOTOX® (onabotulinumtoxinA), our foundational, first FDA-approved preventive treatment for chronic migraine; and UBRELVY® (ubrogepant), an acute treatment for migraine attacks.”
QULIPTA’s expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period.2 The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19.3 The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints.3 This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine.4 These efficacy results are consistent with those in the ADVANCE episodic migraine trial.5
“The FDA approval is an important milestone, providing those most impacted by migraine with a new, safe and effective treatment option in a convenient, once-daily pill,” said Peter McAllister, M.D., Director of the New England Center for Neurology and Headache. “QULIPTA’s data demonstrate that it helps reduce the burden of migraine by delivering improvements in function, with high response rates and sustained efficacy over 12 weeks. These are critical factors neurologists and headache specialists consider when prescribing a treatment option, particularly for those with chronic migraine.”
QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is indicated for the preventive treatment of chronic migraine. The overall safety profile of QULIPTA is consistent with the episodic migraine patient population, with the most common adverse events including constipation, nausea and fatigue/sleepiness.6
“For years, I felt hopeless and struggled to find a treatment that not only reduced the number of migraine attacks but could also help reduce how often migraine impacted my daily activities like taking my kids to school or practices,” said Latoya Lawrence, a patient who has lived with migraine for more than 20 years. “After I started taking QULIPTA for my episodic migraine, I wasn’t as worried about when my next migraine attack might strike. I’m glad people living with chronic migraine now have a treatment option that has the potential to make a substantial impact on their lives.”
About the Phase 3 PROGRESS Clinical Trial
The Phase 3 PROGRESS clinical trial evaluated the safety, tolerability and efficacy of oral QULIPTA 60mg once daily (QD) for the preventive treatment of chronic migraine.7 The patient population for the study included patients with a diagnosis of chronic migraine for at least one year, and greater than or equal to 15 headache days with greater than or equal to eight migraine days in the 28 days prior to randomization.7 The primary endpoint measured the reduction from baseline in mean monthly migraine days compared to placebo across a 12-week treatment period.7
Key secondary endpoints across the 12-week treatment period included: change from baseline in mean monthly headache days; change from baseline in mean monthly acute medication use days; proportion of participants with at least a 50% reduction in mean monthly migraine days; and change from baseline in Migraine Specific Quality of Life Questionnaire version 2.1 (MSQ v2.1) Role Function-Restrictive domain score at Week 12. The MSQ v2.1 is a questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past four weeks. Key secondary endpoints also included change from baseline in Activity Impairment in Migraine-Diary (AIM-D) Performance of Daily Activities and Physical Impairment domain scores. The AIM-D is a novel questionnaire designed to evaluate difficulty with performance of daily activities and physical impairment due to migraine.
About QULIPTA® (atogepant)
QULIPTA® is approved by the U.S. Food and Drug Administration (FDA) and is available in the United States for the preventive treatment of migraine in adults. QULIPTA is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. CGRP and its receptors are expressed in regions of the nervous system associated with migraine pathophysiology, and studies have shown that CGRP levels are elevated during migraine attacks. QULIPTA blocks CGRP through a once-daily dose and is available in three strengths for the preventive treatment of episodic migraine – 10 mg, 30 mg and 60 mg. Only the 60 mg dose of QULIPTA is approved for the preventive treatment of chronic migraine.
Please see QULIPTA full Prescribing Information.
INDICATIONS
BOTOX® (onabotulinumtoxinA) is a prescription medicine that is injected into muscles and used:
- To treat overactive bladder symptoms such as a strong need to urinate with leaking or wetting accidents (urge urinary incontinence), a strong need to urinate right away (urgency), and urinating often (frequency) in adults 18 years and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To treat leakage of urine (incontinence) in adults 18 years and older with overactive bladder due to a neurologic disease when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To treat overactive bladder due to a neurologic disease in children 5 years of age and older when another type of medicine (anticholinergic) does not work well enough or cannot be taken
- To prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years and older
- To treat increased muscle stiffness in people 2 years of age and older with spasticity
- To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in people 16 years and older
- To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids (blepharospasm) in people 12 years of age and older
BOTOX is also injected into the skin to treat the symptoms of severe underarm sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well enough in people 18 years and older.
It is not known whether BOTOX is safe and effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).
BOTOX has not been shown to help people perform task-specific functions with their upper limbs or increase movement in joints that are permanently fixed in position by stiff muscles.
It is not known whether BOTOX is safe and effective for severe sweating anywhere other than your armpits.
Please see BOTOX® full Product Information, including Boxed Warning and Medication Guide.
About UBRELVY® (ubrogepant)
UBRELVY® is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the acute treatment of migraine with or without aura in adults that is an option for a wide range of patients who experience migraine attacks. UBRELVY® is the first pill of its kind to directly block CGRP, a protein released during a migraine attack, from binding to its receptors.
What is UBRELVY® (ubrogepant)?
UBRELVY is a prescription medicine used for the acute treatment of migraine attacks with or without aura in adults. UBRELVY is not used to prevent migraine headaches.
Please see UBRELVY full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.
About Migraine and Chronic Migraine
Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea.8 It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.9-12
People living with chronic migraine experience headaches or migraine for 15 or more days per month, with at least eight of those days associated with migraine.13 It is differentiated from episodic migraine, which is characterized by 0-14 headache days per month,14 by its more debilitating disease profile including greater prevalence of comorbid conditions as well as higher frequency of headache and migraine days.14-16 Individuals with chronic migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life. This results in substantial societal and familial burden.17-21 Significant direct and indirect costs are also associated with chronic migraine, leading to economic burden for patients and healthcare systems.22-24
About AbbVie in Migraine
AbbVie is the only company with three prescription treatments designed to meet patient needs across the full spectrum of migraine to help patients living with this debilitating disease.
- QULIPTA® (atogepant) is FDA-approved for the preventive treatment of migraine in adults. It is the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent migraine across frequencies, including episodic and chronic. Since its initial approval for the preventive treatment of episodic migraine in September 2021, QULIPTA has been prescribed for nearly 200,000 patients.
- BOTOX® (onabotulinumtoxinA) is the first FDA-approved, preventive treatment for adult patients with chronic migraine. Since FDA approval in 2010, more than 5 million BOTOX® treatments given to more than 850,000 people living with chronic migraine.
- UBRELVY® (ubrogepant) is the first FDA-approved CGRP treatment for the acute treatment of migraine attacks in adults. Since its approval in December 2019, UBRELVY® has been prescribed for nearly 750,000 patients. It can be used in patients across the entire spectrum of migraine and regardless of other treatments (acute or preventive) they may be on or have tried.
At AbbVie, we are committed to empowering people living with migraine disease. We advance science that enables healthcare providers to care for people impacted across the spectrum of migraine. Through education and partnerships with the migraine community, we strive to help those with migraine navigate barriers to care, access effective treatments and reduce the impact of migraine on their lives.
About AbbVie in Neuroscience
At AbbVie, our commitment to preserve the personhood of those living with neurological and psychiatric disorders is unwavering. Every challenge in this uncharted territory makes us more determined and drives us harder to discover and deliver solutions for patients, care partners and clinicians. AbbVie’s Neuroscience portfolio consists of approved therapies in neurological and psychiatric disorders, including bipolar I disorder, cervical dystonia, major depressive disorder, migraine, Parkinson’s disease, post-stroke spasticity, schizophrenia and others along with a robust pipeline.
We have a strong investment in neuroscience research, with our Foundational Neuroscience Center in Cambridge, Massachusetts, and our Neuroscience Discovery site in Ludwigshafen, Germany, where our research and resilience in these challenging therapeutic areas is yielding a deeper understanding of the pathophysiology of neurological and psychiatric disorders, and identifying targets for potential disease-modifying therapeutics aimed at making a difference in people’s lives.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and gastroenterology, in addition to products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- AbbVie. Data on File: ABVRRTI73750
- Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137?term=NCT03855137&draw=2&rank=1. Accessed on March 15, 2023.
- AbbVie. Data on File: ABVRRTI73750
- 12-Week Placebo-controlled Study of Atogepant for the Preventive Treatment of Migraine in Participants With Episodic Migraine ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03777059.
- QULIPTA™ (atogepant) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- Efficacy, Safety, and Tolerability, of Atogepant for the Prevention of Chronic Migraine. ClinicalTrials.gov. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03855137.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Amiri P, Kazeminasab S, Nejadghaderi SA, Mohammadinasab R, Pourfathi H, Araj-Khodaei M, Sullman MJM, Kolahi AA, Safiri S. Migraine: A Review on Its History, Global Epidemiology, Risk Factors, and Comorbidities. Front Neurol. 2022 Feb 23;12:800605. doi: 10.3389/fneur.2021.800605. PMID: 35281991; PMCID: PMC8904749.
- Steiner, T. J., Stovner, L. J., Vos, T., Jensen, R., & Katsarava, Z. Migraine is first cause of disability in under 50s: Will health politicians now take notice? J Headache Pain. 2018;19:17.
- AbbVie. Data on File: ABVRRTI73750
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
- Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38:1-211.
- Katsarava Z, Buse DC, Manack AN, Lipton RB. Defining the differences between episodic migraine and chronic migraine. Curr Pain Headache Rep. 2012;16:86-92.
- Buse DC, Manack A, Serrano DC, et al. Sociodemographic and comorbidity profiles of chronic migraine and episodic migraine sufferers. J Neurol Neurosurg Psychiatry. 2010;81:428-432.
- Adams AM, Serrano D, Buse DC, et al. The impact of chronic migraine: The Chronic Migraine Epidemiology and Outcomes (CaMEO) Study methods and baseline results. Cephalalgia. 2015;35(7) 563-578.
- Blumenfeld A, Varon S, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.
- Lantéri-Minet M, Duru G, Mudge M, Cottrell S. Quality of life impairment, disability and economic burden associated with chronic daily headache, focusing on chronic migraine with or without medication overuse: a systematic review. Cephalalgia. 2011;31:837-850.
- Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO Study. Mayo Clin Proc. 2016;91:596-611.
- Buse DC, Powers SW, Gelfand AA, et al. Adolescent perspectives on the burden of a parent’s migraine: results from the CaMEO study. Headache. 2018;58:512-524.
- Buse DC, Murray S, Dumas PK, et al. Life with migraine, effect on relationships, career and finances, and overall health and well-being results of the Chronic Migraine Epidemiology and Outcomes (CaMEO) Study. Cephalalgia. 2018;38(Suppl 1):9-10.
- Messali A, Sanderson JC, Blumenfeld AM, et al. Direct and indirect costs of chronic and episodic migraine in the United States: a web-based survey. Headache. 2016;56:306-322.
- Sanderson JC, Devine EB, Lipton RB, et al. Headache-related health resource utilization in chronic and episodic migraine across six countries. J Neurol Neurosurg Psychiatry. 2013;84:1309-1317.
- Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: Results from the International Burden of Migraine Study (IBMS). Cephalalgia. 2011;31:301-315.
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