Revance to Present New DAXXIFY® Data at the American Academy of Neurology 2024 Annual Meeting

Published 8 months ago via Business Wire

– Two presentations highlighting data on DAXXIFY® for the treatment of cervical dystonia, including a new analysis from ASPEN trials assessing patient-desired retreatment intervals and one abstract examining the influence of DAXXIFY’s formulation on clinical performance

Revance Therapeutics, Inc. (NASDAQ: RVNC), today announced two poster presentations on DAXXIFY® for the treatment of cervical dystonia at the annual meeting of American Academy of Neurology (AAN), taking place April 13-18, 2024, in Denver, Colorado.

In the ASPEN-1 and ASPEN-OLS (open label study), a new analysis found that among patients that requested early retreatment with DAXXIFY®, roughly 50% of peak efficacy remained at the time of their request. In the ASPEN-OLS 52-week long-term follow-up study, approximately 60% of retreatments were at 16 weeks or later. These findings suggest that the long-acting symptom control with DAXXIFY® allows physicians the flexibility to customize treatment intervals for each patient, without being limited by the FDA and payer-defined minimum treatment interval of 12 weeks (as is the case with conventional neurotoxins). Additionally, the studies show that adverse event rates remained low across all retreatment scenarios.

“While it may not be surprising that many patients prefer to be retreated as their symptoms first re-emerge rather than waiting to return to baseline, we believe that the duration of DAXXIFY offers the potential for physicians to tailor doses and retreatment intervals to the needs of individual patients, in order to provide sustained symptom control and reduce the symptom rollercoaster experienced by a vast number of those suffering with cervical dystonia,” said David. A. Hollander, MD, MBA, Chief Medical Officer and Global Therapeutics Franchise Lead.

A second poster, by Dr. Han Lee and colleagues, examines DAXXIFY’s novel formulation and the role of Revance’s custom-engineered peptide (RTP004), in clinical performance. The data shows that the benefits of RTP004 include increased binding of neurotoxin to cell membranes to allow more toxin to enter the neuron, enhanced SNAP-25 cleavage in neurons in a dose-dependent manner, and localization in the injected muscle. By increasing bioavailability, DAXXIFY’s formulation allows for a lower amount of core neurotoxin to be administered while maintaining long lasting benefit, which may contribute to the strong safety and differentiated performance profile.

Poster Details:

  • Title: Efficacy Remaining at Time of Requested Retreatment Following Botulinum Toxin Treatment for Cervical Dystonia: Potential for a New Treatment Paradigm With DaxibotulinumtoxinA
  • Authors and Affiliation: Aaron Ellenbogen, Robert A. Hauser, Atul Patel, Peter McAllister, Domenico Vitarella, Todd Gross, Rashid Kazerooni, Conor J. Gallagher, David A. Hollander, Michigan Institute for Neurological Disorders, Farmington Hills, MI, USA; University of South Florida, Tampa, FL, USA; Kansas City Bone & Joint Clinic, Overland Park, KS, USA; New England Institute for Neurology and Headache, Stamford, CT, USA; Revance Therapeutics, Inc., Nashville, TN, USA
  • Title: Influence of Novel Formulation in DaxibotulinumtoxinA on Efficacy for Treatment of Cervical Dystonia
  • Authors and Affiliation: Han Lee, André F. Batista, Conor J. Gallagher, The Permanente Medical Group, San Leandro, CA, USA; Revance Therapeutics, Inc., Nashville, TN, USA

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.

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.1-5 Manufactured in the U.S., DAXXIFY is the first true innovation in neuromodulator product formulation in over 30 years.

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.

Forward-Looking Statements

Any statements in this press release that are not statements of historical fact, including statements related to the potential benefits, safety, efficacy and duration (including treatment intervals) of DAXXIFY® for the treatment of cervical dystonia; our opportunity in aesthetics and therapeutics; the potential to set a new standard in healthcare; patient outcomes and physician experiences; development of an onobotulinumtoxinA biosimilar with our partner, Viatris; and commercialization of DAXXIFY® in China with our partner, Shanghai Fosun Pharmaceutical; 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 and the timing of events to differ materially from our expectations. These risks and uncertainties relate to, 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, supply chain and operational efficiencies; our financial performance and the economics of DAXXIFY and the RHA Collection of dermal fillers; 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; 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 "Risk Factors" in our Form 10-K for the year ended December 31, 2023, filed with the SEC on February 28, 2024. 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.

SOURCES

  1. 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.
  2. Data on file. ASPEN CSR. Revance. Newark, CA: Revance Therapeutics, Inc., 2018.
  3. DAXXIFY. Prescribing Information. Revance Therapeutics, Inc, 2022.
  4. 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.
  5. 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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