Revance Receives Permanent J-Code for DAXXIFY® and Announces Publication of DAXXIFY Pivotal Study (ASPEN-1) Results in Neurology®
- CMS streamlines reimbursement for DAXXIFY with assignment of permanent J-code -
- Peer-reviewed publication of DAXXIFY pivotal data in therapeutics reinforces the products long duration of effect and favorable safety profile -
The company also announced today the publication of results from the ASPEN-1 Pivotal Phase 3 study in Neurology®, the medical journal of the
“We are very pleased to receive our permanent J-Code for DAXXIFY as we continue to make great progress with our cervical dystonia PrevU program and prepare for launch,” said
“As an investigator in all stages of the ASPEN program and a participating physician in the DAXXIFY CD PrevU program, I’m happy to see publication of the pivotal study results in a peer-reviewed journal for the neurology community,” said
The pivotal Phase 3 clinical study (ASPEN 1), included 301 patients randomized to receive 125 U or 250U of DAXXIFY, or to placebo.1-2 DAXXIFY was shown to be effective, generally safe, and well tolerated across both dose groups, 125U and 250U. 1-2 The primary endpoint was met in both groups, with 12.7 and 10.9 point reductions from baseline in Total TWSTRS score averaged over Weeks 4 and 6 (p<0.01 vs placebo).1-2 Median duration of effect, defined as >80% loss of peak effect, was 24.0 and 20.3 weeks for the two dose groups respectively. 1-2 The low incidence rates of dysphagia (1.9% and 3.6%, respectively) and muscle weakness (4.7% and 2.3%, respectively), further support DAXXIFY’s safety profile.1-2 The Phase 3 clinical program also included a repeat-treatment, open-label safety study (
The total
The full publication can be accessed via Neurology.org.
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.
WARNING: DISTANT SPREAD OF TOXIN EFFECT
The effects of DAXXIFY® and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. DAXXIFY® is not approved for the treatment of spasticity or any conditions other than cervical dystonia and glabellar lines.
IMPORTANT SAFETY INFORMATION
Contraindications
DAXXIFY® contraindications include hypersensitivity to any botulinum toxin preparation or any of the components in the formulation and infection at the injection site(s).
Warnings and Precautions
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
The potency units of DAXXIFY® are not interchangeable with preparations of other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded. Patients should seek immediate medical attention if respiratory, speech or swallowing difficulties occur. Use caution when administering to patients with pre-existing cardiovascular disease. Concomitant neuromuscular disorders may exacerbate clinical effects of treatment.
Adverse Reactions
The most commonly observed adverse reactions are:
Glabellar lines (≥1%): headache (6%), eyelid ptosis (2%) and facial paresis (1%).
Cervical dystonia (≥5%): headache (9%), injection site pain (8%), injection site erythema (5%), muscular weakness (5%), and upper respiratory tract infection (5%).
Drug Interactions
Co-administration of DAXXIFY® and aminoglycoside antibiotics, anticholinergic agents or any other agents interfering with neuromuscular transmission or muscle relaxants should only be performed with caution as the effect of DAXXIFY® may be potentiated. The effect of administering different botulinum neurotoxins during course of treatment with DAXXIFY® is unknown.
Use in Specific Populations
DAXXIFY® is not recommended for use in children or pregnant women.
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
Please see DAXXIFY important safety information below and full Prescribing Information, including Boxed Warning and Medication Guide.
About Cervical Dystonia
According to the
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
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
Revance is headquartered in
“Revance”, the Revance logo, and DAXXIFY are registered trademarks of
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to patient access and physician reimbursement for DAXXIFY® for cervical dystonia; our market opportunity; the potential benefits, safety, efficacy and duration of DAXXIFY®; our opportunity in therapeutics; the extent to which our products are unique or innovative; the potential to set a new standard of care; development of a biosimilar to BOTOX® with our partner, Viatris; statements about our business strategy, timeline and other goals, plans and prospects, including with respect to DAXXIFY®; the possibility for international commercialization; and the outcomes for and experiences of patients and physicians, including with respect to real world results remaining consistent with study results; constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will ever be achieved or occur.
Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties relate, but are not limited to: our ability to obtain funding for our operations; the timing of capital expenditures; the accuracy of our estimates regarding expenses, revenues, capital requirements, cost savings related to the divestiture of the OPUL payments business and supply chain and operational efficiencies; our financial performance and the economics of DAXXIFY® and the RHA® Collection of dermal fillers; the extent of future impairment charges; our ability to comply with our debt obligations; the impact of macroeconomic factors on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, regulatory meetings, inspections and approvals, clinical trials and other aspects of our business and on the market; our ability to maintain approval of our products; our ability and the ability of our partners to manufacture supplies for DAXXIFY® and our drug product candidates; our ability to acquire supplies of the RHA® Collection of dermal fillers; the uncertain clinical development process; our ability to obtain, and the timing relating to, regulatory submissions and approvals with respect to our drug product candidates and third-party manufacturers; the risk that clinical trials may not have an effective design or generate positive results or that positive results would assure regulatory approval or commercial success; the applicability of clinical study results to actual outcomes; the rate and degree of economic benefit, safety, efficacy, duration, commercial acceptance, market, competition and/or size and growth potential of DAXXIFY®, the RHA® Collection of dermal fillers, and our drug product candidates, if approved; our ability to successfully commercialize DAXXIFY® and to continue to successfully commercialize the RHA® Collection of dermal fillers; the timing and cost of commercialization activities; securing or maintaining adequate coverage or reimbursement by third-party payers for DAXXIFY®; the proper training and administration of our products by physicians and medical staff; our ability to maintain and gain acceptance from injectors and physicians in the use of DAXXIFY® for aesthetic and therapeutic indications; our ability to strengthen professional partnerships; our ability to expand sales and marketing capabilities; the status of commercial collaborations; our ability to effectively manage the exit of the OPUL payments business; changes in and failures to comply with laws and regulations; our ability to continue obtaining and maintaining intellectual property protection for our products; the cost and our ability to defend ourselves in product liability, intellectual property, class action or other lawsuits; our ability to limit or mitigate cybersecurity incidents; the volatility of our stock price; and other risks.. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in our periodic filings with the
SOURCES
-
Comella C, Ferreira JJ, Pain E, Azoulai M,
Om S. Patient perspectives on the therapeutic profile of botulinum neurotoxin type A in cervical dystonia. J Neurol 2020;268:903-912. -
Data on file. ASPEN CSR. Revance.
Newark, CA :Revance Therapeutics, Inc. , 2018. -
Data on file. ASPEN OLS CSR. Revance.
Newark, CA :Revance Therapeutics, Inc. , 2018 - Market size as of 2023. CAGRs represent projected estimates. Decision Resources Group Therapeutic Botulinum Toxin Market Analysis Global 2024.
-
DAXXIFY. Prescribing Information.
Revance Therapeutics, Inc , 2022. - Fabi SG, Cohen JL, Green LJ, et al. DaxibotulinumtoxinA for Injection for the treatment of glabellar lines: efficacy results from SAKURA 3, a large, open label, phase 3 safety study. Dermatol Surg. 2020;47(1):48-54.
- Waugh JM, Lee J, Dake MD, Browne D. Nonclinical and clinical experiences with CPP-based self-assembling peptide systems in topical drug development. Methods Mol Biol. 2011;683:553-572.
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Investors
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or
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Media
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