NASHVILLE, Tenn. / Feb 02, 2024 / Business Wire / Revance Therapeutics, Inc. (RVNC) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J0589) for DAXXIFY®, indicated for the treatment of cervical dystonia in adults. J-Codes are product-specific reimbursement codes used by commercial insurance plans, Medicare, and other government payers and are intended to simplify reimbursement for providers and expand access for patients.
The company also announced today the publication of results from the ASPEN-1 Pivotal Phase 3 study in Neurology®, the medical journal of the American Academy of Neurology. The study, authored by Cynthia L. Comella, M.D., evaluated the safety, duration of response, and efficacy of two doses of DAXXIFY for the treatment of cervical dystonia (CD), and served as the foundation for Food and Drug Administration (FDA) approval of DAXXIFY for the treatment of cervical dystonia in August 2023.
“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 Mark J. Foley, Chief Executive Officer. “Thanks to the hard work of our therapeutics team, we have received our reimbursement code, secured coverage for over 100 million commercial lives from top payers across the country and are on track to commercialize DAXXIFY in the therapeutics market mid-year. Further, our confidence in DAXXIFY’s ability to deliver a favorable duration and safety profile in real-world cervical dystonia patients continues to grow based on positive feedback from our PrevU physicians and the over 250 patients that have been treated to date in the PrevU program. Based on DAXXIFY’s unique clinical profile, our early clinical experience and advances in our reimbursement and coverage efforts, we look forward to providing patients suffering from cervical dystonia with a compelling alternative to their conventional treatment options.”
“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 Atul Patel, M.D., MHSA. “Importantly, the real-world clinical results of DAXXIFY from the patients I have injected so far in PrevU, including safety, efficacy and duration, are in-line with those seen in the ASPEN-1 study. By offering a long duration of treatment effect, DAXXIFY can help reduce symptom reoccurrence between injections, which is experienced by most patients being treated with conventional botulinum toxins. This would represent a significant advancement in the treatment of cervical dystonia, something we have not seen in decades.”
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 (ASPEN OLS) that allowed for up to 4 additional DAXXIFY treatments, which reinforced the findings of ASPEN-1.3
The total U.S. therapeutic neuromodulator market opportunity for DAXXIFY is $2.7 billion, which includes the over $350 million cervical dystonia market.4
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 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.1-2, 5-7 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 is headquartered in Nashville, Tenn., with additional office locations in Newark and Irvine, Calif. Learn more at www.Revance.com, www.RevanceAesthetics.com, www.DAXXIFY.com, https://hcp.daxxifytherapy.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.
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 Securities and Exchange Commission (SEC), including factors described in the section entitled "Risks Factors" on our Form 10-K filed with the SEC on February 28, 2023 and including, without limitation, our Form 10-Qs for the quarters ended March 31, 2023, June 30, 2023 and September 30, 2023, filed with the SEC on May 9, 2023, August 8, 2023 and November 8, 2023, respectively. The forward-looking statements in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.
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November 07, 2024 August 08, 2024 May 09, 2024 | |
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