– Positive opinion based on three global Phase 3 pivotal studies evaluating the safety and efficacy of RINVOQ (15 mg or 30 mg, once daily) used with or without topical corticosteroids in adults and adolescents with moderate to severe atopic dermatitis[1],[2]
– If approved, this will be the fourth indication for RINVOQ in the European Union[3]
– The European Commission decision is anticipated in the third quarter of 2021
NORTH CHICAGO, IL, USA I June 25, 2021 I AbbVie (NYSE: ABBV) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis who are candidates for systemic therapy. RINVOQ is being studied in several immune-mediated inflammatory diseases.4-10
The CHMP positive opinion was supported by data from the global Phase 3 program evaluating more than 2,500 patients with moderate to severe atopic dermatitis across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up.1,2 Across the three studies, both doses of RINVOQ met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in itch compared to placebo at week 16 and other time points (p<0.001) in patients with moderate to severe atopic dermatitis.1,2 The most commonly reported adverse events in patients treated with RINVOQ were acne, nasopharyngitis and upper respiratory tract infections.1,2
“This milestone is an important step forward in our journey to improve care for people living with atopic dermatitis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “Despite available treatments, many people with moderate to severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. If approved, this will be the fourth indication for RINVOQ, and RINVOQ will be the first JAK inhibitor in the European Union to treat moderate to severe atopic dermatitis in both adults and adolescents 12 years and older.3
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.11,12 It affects up to an estimated 10 percent of adults and 25 percent of children.12,13 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease.14 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.12,15
About the RINVOQ Atopic Dermatitis Global Phase 3 Study Program
The global Phase 3 program evaluated more than 2,500 patients worldwide across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up.1,2 The studies evaluated the efficacy and safety of RINVOQ (15 mg and 30 mg, once daily), with and without topical corticosteroids (TCS), in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic therapy.1,2 The co-primary endpoints across all three studies were at least a 75 percent improvement in Eczema Area and Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score 0/1 at week 16.1,2 Secondary endpoints included reduction of itch defined as ≥4 point improvement in Worst Pruritus Numerical Rating Scale (NRS) from baseline at week 16 and other timepoints, as well as EASI 90 and EASI 100 at week 16.1,2 More information on this program can be found at www.clinicaltrials.gov (NCT03569293, NCT03607422, NCT03568318).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-10 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.3 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in these indications is 15 mg. Phase 3 trials of RINVOQ in axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.4-10 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy are under evaluation by regulatory authorities.
Please see the full SmPC for complete prescribing information at http://www.EMA.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
References:
- Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate, double-blind, randomized controlled phase 3 studies. Lancet. doi:10.1016/s0140-6736(21)00588-2.
- Reich K., et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. doi:10.1016/s0140-6736(21)00589-4.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on June 1, 2021.
- A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on June 1, 2021.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on June 1, 2021.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on Accessed on June 1, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026. Accessed on June 1, 2021.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on June 1, 2021.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on June 1, 2021.
- Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16. doi: 10.1159/000370220.
- Weidinger, S., et al. Atopic dermatitis. Nat Rev Dis Primers 4, 1(2018). doi: 10.1038/s41572-018-0001-z.
- Eichenfield L.F., et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010.
- Shrestha S., et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Adv Ther. 2017;34(8):1989–2006.
- EFA. Atopic Eczema: Itching for Life Report. 2018. Available at: https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf. Accessed on June 1, 2021.
SOURCE: AbbVie
Post Views: 32
– Positive opinion based on three global Phase 3 pivotal studies evaluating the safety and efficacy of RINVOQ (15 mg or 30 mg, once daily) used with or without topical corticosteroids in adults and adolescents with moderate to severe atopic dermatitis[1],[2]
– If approved, this will be the fourth indication for RINVOQ in the European Union[3]
– The European Commission decision is anticipated in the third quarter of 2021
NORTH CHICAGO, IL, USA I June 25, 2021 I AbbVie (NYSE: ABBV) today announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of RINVOQ® (upadacitinib), an oral, selective and reversible JAK inhibitor, for the expanded use in adults (15 mg or 30 mg, once daily) and adolescents 12 years and older (15 mg, once daily) with moderate to severe atopic dermatitis who are candidates for systemic therapy. RINVOQ is being studied in several immune-mediated inflammatory diseases.4-10
The CHMP positive opinion was supported by data from the global Phase 3 program evaluating more than 2,500 patients with moderate to severe atopic dermatitis across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up.1,2 Across the three studies, both doses of RINVOQ met all primary and secondary endpoints, demonstrating rapid and significant improvement in skin clearance and reduction in itch compared to placebo at week 16 and other time points (p<0.001) in patients with moderate to severe atopic dermatitis.1,2 The most commonly reported adverse events in patients treated with RINVOQ were acne, nasopharyngitis and upper respiratory tract infections.1,2
“This milestone is an important step forward in our journey to improve care for people living with atopic dermatitis,” said Michael Severino, M.D., vice chairman and president, AbbVie. “Despite available treatments, many people with moderate to severe forms of this disease continue to experience a relentless and burdensome cycle of skin and itch symptoms. We are encouraged that the CHMP has recognized RINVOQ’s potential as an additional treatment option for these patients.”
The CHMP positive opinion is a scientific recommendation for marketing authorization to the European Commission, which authorizes marketing approval in the European Union. The Marketing Authorization will be valid in all member states of the European Union, as well as Iceland, Liechtenstein, Norway and Northern Ireland. If approved, this will be the fourth indication for RINVOQ, and RINVOQ will be the first JAK inhibitor in the European Union to treat moderate to severe atopic dermatitis in both adults and adolescents 12 years and older.3
About Atopic Dermatitis
Atopic dermatitis is a chronic, relapsing inflammatory condition characterized by a cycle of intense itching and scratching leading to cracked, scaly, oozing skin.11,12 It affects up to an estimated 10 percent of adults and 25 percent of children.12,13 Between 20 and 46 percent of adults with atopic dermatitis have moderate to severe disease.14 The range of symptoms poses significant physical, psychological and economic burden on individuals impacted by the disease.12,15
About the RINVOQ Atopic Dermatitis Global Phase 3 Study Program
The global Phase 3 program evaluated more than 2,500 patients worldwide across three global pivotal studies: Measure Up 1, Measure Up 2 and AD Up.1,2 The studies evaluated the efficacy and safety of RINVOQ (15 mg and 30 mg, once daily), with and without topical corticosteroids (TCS), in adults and adolescents with moderate to severe atopic dermatitis who were candidates for systemic therapy.1,2 The co-primary endpoints across all three studies were at least a 75 percent improvement in Eczema Area and Severity Index (EASI 75) and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score 0/1 at week 16.1,2 Secondary endpoints included reduction of itch defined as ≥4 point improvement in Worst Pruritus Numerical Rating Scale (NRS) from baseline at week 16 and other timepoints, as well as EASI 90 and EASI 100 at week 16.1,2 More information on this program can be found at www.clinicaltrials.gov (NCT03569293, NCT03607422, NCT03568318).
About RINVOQ® (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.1-10 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.3 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. RINVOQ is approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs); for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; and for the treatment of active ankylosing spondylitis (AS) in adult patients who have responded inadequately to conventional therapy. The approved dose for RINVOQ in these indications is 15 mg. Phase 3 trials of RINVOQ in axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.4-10 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy are under evaluation by regulatory authorities.
Please see the full SmPC for complete prescribing information at http://www.EMA.europa.eu.
Globally, prescribing information varies; refer to the individual country product label for complete information.
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, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
References:
- Guttman-Yassky E., et al. Once-daily upadacitinib versus placebo in adolescents and adults with moderate-to-severe atopic dermatitis (Measure Up 1 and Measure Up 2): results from two replicate, double-blind, randomized controlled phase 3 studies. Lancet. doi:10.1016/s0140-6736(21)00588-2.
- Reich K., et al. Safety and efficacy of upadacitinib in combination with topical corticosteroids in adolescents and adults with moderate-to-severe atopic dermatitis (AD Up): results from a randomized, double-blind, placebo-controlled phase 3 trial. Lancet. doi:10.1016/s0140-6736(21)00589-4.
- RINVOQ [Summary of Product Characteristics]. AbbVie Deutschland GmbH & Co. KG; May 2021. Available at: https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf.
- Pipeline – Our Science | AbbVie. AbbVie. 2021. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on June 1, 2021.
- A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on June 1, 2021.
- A Study to Evaluate Efficacy and Safety of Upadacitinib in Adult Participants With Axial Spondyloarthritis (SELECT AXIS 2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04169373. Accessed on June 1, 2021.
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn’s Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on Accessed on June 1, 2021.
- A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis (U-ACCOMPLISH). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03653026. Accessed on June 1, 2021.
- A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on June 1, 2021.
- A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (TAK) (SELECT-TAK). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT04161898. Accessed on June 1, 2021.
- Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66(suppl 1):8–16. doi: 10.1159/000370220.
- Weidinger, S., et al. Atopic dermatitis. Nat Rev Dis Primers 4, 1(2018). doi: 10.1038/s41572-018-0001-z.
- Eichenfield L.F., et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70(2):338-351. doi:10.1016/j.jaad.2013.10.010.
- Shrestha S., et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Adv Ther. 2017;34(8):1989–2006.
- EFA. Atopic Eczema: Itching for Life Report. 2018. Available at: https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf. Accessed on June 1, 2021.
SOURCE: AbbVie
Post Views: 32
