- DAXXIFY® for the treatment of cervical dystonia is the first and only peptide-formulated, long-lasting neurotoxin that offers the potential to improve duration of symptom control1
- Revance has received a Permanent J-Code and has already secured coverage for 78% of commercial lives with top health plans, while also launching patient affordability programs
- Today’s launch provides first entry into the $2.7 billion U.S. therapeutic neurotoxin market with a new and compelling treatment option2
NASHVILLE, TN, USA I May 09, 2024 I Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced the commercial launch of DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia, providing patients and physicians with a compelling new treatment option for a painful and disabling chronic condition.The launch marks Revance’s entry into the large and growing U.S. therapeutics neurotoxinmarket.
“One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments”
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“DAXXIFY provides a significant opportunity for Revance and marks the culmination of our decades-long mission to bring true innovation to the therapeutics market. Between DAXXIFY’s differentiated clinical profile, compelling value proposition and safety profile, DAXXIFY has the potential to address the unmet needs of all stakeholders, including patients, physicians and payers,” said President and Chief Executive Officer, Mark J. Foley.
Following the FDA’s approval of DAXXIFY for cervical dystonia in August 2023, Revance launched the DAXXIFY cervical dystonia PrevU early experience program with the objective of optimizing treatment outcomes for patients and ensuring smooth practice integration. Revance subsequently established its commercial infrastructure in preparation for launch, received a permanent J-Code for DAXXIFY from the U.S. Centers for Medicare & Medicaid Services (CMS) (which streamlines the reimbursement pathway for providers), operationalized reimbursement support services to minimize potential hurdles to adoption, and launched patient affordability programs to support patients with out-of-pocket costs.
“One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments,” said David. A. Hollander, M.D., MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.
Peter McAllister, M.D., co-founder and medical director of the New England Institute for Neurology and Headache, added: “As an investigator in the ASPEN program, and a participating physician in PrevU, I have seen firsthand the potential for DAXXIFY to address a significant unmet need in the treatment of cervical dystonia. Many patients struggle with pain and discomfort coming back between injections with current treatment options, but with DAXXIFY my patients have experienced long lasting symptom relief. Further, DAXXIFY’s safety profile continues to be encouraging over a broad range of doses. As patients can currently only access treatment every 12 weeks based on product labeling and reimbursement guidelines, I’m excited to offer my patients a new therapy that offers sustained symptom control.”
For more information on DAXXIFY® access and availability, visit HCP.DAXXIFYCervicalDystonia.com
DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.
Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.
To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About DAXXIFY
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting, peptide formulated neuromodulator product with approved indications in the U.S. for the temporary improvement of glabellar lines (frown lines) and for the treatment of cervical dystonia in adults. DAXXIFY is powered by Peptide Exchange Technology™, Revance’s proprietary, synthetic, 35-amino-acid stabilizing excipient, and is developed free of human serum albumin or animal-based components.Manufactured in the U.S., DAXXIFY is the first true innovation in neuromodulator product formulation in over 30 years.
Please see DAXXIFY important safety information below and full Prescribing Information, including Boxed Warning and Medication Guide.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).
First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects roughly 60,000 people in the United States.
About Revance
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China.
Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn.
“Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA.
SOURCES
- Data on File. ASPEN-1 Rollover and ASPEN OLS TWSTRS. Newark, CA: Revance Therapeutics, Inc.
- Market size as of 2023. CAGRs represent projected estimates. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2024.
SOURCE: Revance Therapeutics
Post Views: 2,502
- DAXXIFY® for the treatment of cervical dystonia is the first and only peptide-formulated, long-lasting neurotoxin that offers the potential to improve duration of symptom control1
- Revance has received a Permanent J-Code and has already secured coverage for 78% of commercial lives with top health plans, while also launching patient affordability programs
- Today’s launch provides first entry into the $2.7 billion U.S. therapeutic neurotoxin market with a new and compelling treatment option2
NASHVILLE, TN, USA I May 09, 2024 I Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced the commercial launch of DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia, providing patients and physicians with a compelling new treatment option for a painful and disabling chronic condition.The launch marks Revance’s entry into the large and growing U.S. therapeutics neurotoxinmarket.
“One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments”
Post this
“DAXXIFY provides a significant opportunity for Revance and marks the culmination of our decades-long mission to bring true innovation to the therapeutics market. Between DAXXIFY’s differentiated clinical profile, compelling value proposition and safety profile, DAXXIFY has the potential to address the unmet needs of all stakeholders, including patients, physicians and payers,” said President and Chief Executive Officer, Mark J. Foley.
Following the FDA’s approval of DAXXIFY for cervical dystonia in August 2023, Revance launched the DAXXIFY cervical dystonia PrevU early experience program with the objective of optimizing treatment outcomes for patients and ensuring smooth practice integration. Revance subsequently established its commercial infrastructure in preparation for launch, received a permanent J-Code for DAXXIFY from the U.S. Centers for Medicare & Medicaid Services (CMS) (which streamlines the reimbursement pathway for providers), operationalized reimbursement support services to minimize potential hurdles to adoption, and launched patient affordability programs to support patients with out-of-pocket costs.
“One of our primary goals has been to minimize barriers and ensure access to DAXXIFY for the large number of CD patients who have early symptom re-emergence and are not adequately controlled on current toxin treatments,” said David. A. Hollander, M.D., MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.
Peter McAllister, M.D., co-founder and medical director of the New England Institute for Neurology and Headache, added: “As an investigator in the ASPEN program, and a participating physician in PrevU, I have seen firsthand the potential for DAXXIFY to address a significant unmet need in the treatment of cervical dystonia. Many patients struggle with pain and discomfort coming back between injections with current treatment options, but with DAXXIFY my patients have experienced long lasting symptom relief. Further, DAXXIFY’s safety profile continues to be encouraging over a broad range of doses. As patients can currently only access treatment every 12 weeks based on product labeling and reimbursement guidelines, I’m excited to offer my patients a new therapy that offers sustained symptom control.”
For more information on DAXXIFY® access and availability, visit HCP.DAXXIFYCervicalDystonia.com
DAXXIFY® (daxibotulinumtoxinA-lanm) injection IMPORTANT SAFETY INFORMATION INDICATIONS
DAXXIFY® (daxibotulinumtoxinA-lanm) injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients and for the treatment of cervical dystonia in adults.
Please see DAXXIFY® full Prescribing Information, including Boxed Warning and Medication Guide.
To report side effects associated with DAXXIFY®, please visit safety.revance.com, or call 1-877-373-8669. You may also report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
About DAXXIFY
DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection is the first and only FDA approved long-lasting, peptide formulated neuromodulator product with approved indications in the U.S. for the temporary improvement of glabellar lines (frown lines) and for the treatment of cervical dystonia in adults. DAXXIFY is powered by Peptide Exchange Technology™, Revance’s proprietary, synthetic, 35-amino-acid stabilizing excipient, and is developed free of human serum albumin or animal-based components.Manufactured in the U.S., DAXXIFY is the first true innovation in neuromodulator product formulation in over 30 years.
Please see DAXXIFY important safety information below and full Prescribing Information, including Boxed Warning and Medication Guide.
About Cervical Dystonia
According to the Dystonia Medical Research Foundation, cervical dystonia is a painful condition in which the neck muscles contract involuntarily, causing abnormal movements and awkward posture of the head and neck. The movements may be sustained (tonic), jerky (clonic), or a combination. Cervical dystonia (also referred to as spasmodic torticollis) may be primary (meaning that it is the only apparent neurological disorder, with or without a family history) or may be the result of secondary causes (such as physical trauma).
First-line treatment for cervical dystonia is usually neuromodulator (botulinum toxin) injections, but additional treatments can include oral medications, surgery, and complementary therapies. Neuromodulators block the communication between the nerve and the muscle, relaxing the muscle, which alleviates abnormal involuntary movements and postures. Cervical dystonia can occur at any age, although most individuals first experience symptoms in middle age. The condition affects roughly 60,000 people in the United States.
About Revance
Revance is a biotechnology company setting the new standard in healthcare with innovative aesthetic and therapeutic offerings that enhance patient outcomes and physician experiences. Revance’s portfolio includes DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection and the RHA® Collection of dermal fillers in the U.S. Revance has also partnered with Viatris Inc. to develop a biosimilar to onabotulinumtoxinA for injection and Shanghai Fosun Pharmaceutical to commercialize DAXXIFY® in China.
Revance’s global headquarters and experience center is located in Nashville, Tennessee. Learn more at Revance.com, RevanceAesthetics.com, DAXXIFY.com, HCP.DAXXIFYCervicalDystonia.com, or connect with us on LinkedIn.
“Revance”, the Revance logo, and DAXXIFY are registered trademarks of Revance Therapeutics, Inc. Resilient Hyaluronic Acid® and RHA are trademarks of TEOXANE SA.
SOURCES
- Data on File. ASPEN-1 Rollover and ASPEN OLS TWSTRS. Newark, CA: Revance Therapeutics, Inc.
- Market size as of 2023. CAGRs represent projected estimates. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2024.
SOURCE: Revance Therapeutics
Post Views: 2,502
