Revance to Showcase Clinical Findings at The Aesthetic Meeting 2021 that Supports DaxibotulinumtoxinA’s 24-Week Long Duration Profile Across Multiple Female Age Cohorts
Revance Therapeutics (Nasdaq: RVNC) announced a presentation at The American Society for Aesthetic Plastic Surgery Aesthetic Meeting 2021, highlighting data from the Phase 3 SAKURA clinical program. This analysis demonstrated the efficacy, safety, and duration of DaxibotulinumtoxinA for Injection in treating glabellar lines across various female age groups. With over 3,000 subjects, the data confirmed a median time to loss of none or mild symptoms lasting at least 24 weeks. Revance is seeking FDA approval for this treatment, aiming to transform patient experiences in the aesthetic and therapeutic markets.
- Data from the Phase 3 SAKURA clinical program supports the efficacy and safety of DaxibotulinumtoxinA for Injection.
- Median duration of effect was reported at least 24 weeks across all age cohorts for glabellar line treatment.
- None.
Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced an upcoming presentation at The American Society for Aesthetic Plastic Surgery (ASAPS) Aesthetic Meeting 2021, being held at The Miami Beach Convention Center in Miami Beach, FL from April 29 – May 3, 2021. The video presentation will include data from a subgroup analysis from the Phase 3 SAKURA clinical program demonstrating the efficacy, duration, and safety of DaxibotulinumtoxinA for Injection in adult females across multiple age cohorts following the treatment of glabellar lines.
DaxibotulinumtoxinA for Injection is a novel botulinum toxin type A for which Revance is currently seeking FDA approval for the treatment of glabellar lines (GL). It is generally accepted that as age increases, the efficacy of botulinum toxin decreases. This has been demonstrated in multiple studies with current aesthetic botulinum toxin products. The subgroup analysis from the Phase 3 SAKURA clinical program for glabellar lines (GL), which is the largest program for GL with over 3,000 subjects, examined the effects of DaxibotulinumtoxinA for Injection on GL among female subjects ages: 18-45, >45-55, and >55. A further analysis was performed on female subjects <65 and ≥65 years. The data from the analysis showed that DaxibotulinumtoxinA for Injection was safe, effective and delivered a median time to loss of none or mild of at least 24 weeks across all female age groups.
“We look forward to sharing the positive results from our Phase 3 SAKURA program at this year’s Aesthetic Meeting,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The data demonstrates DaxibotulinumtoxinA for Injection’s 24-week duration independent of age in women, in addition to its positive efficacy and safety endpoints in each subgroup analysed.”
The abstracts are available online via the ASAPS website at surgery.org.
Video Presentation:
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Title: DaxibotulinumtoxinA for Injection Demonstrates Consistent Efficacy, Duration, and Safety in Females Independent of Age: Subgroup Analysis from a Large, Phase 3 Program (SAKURA)
Authors and Affiliations: Glynis Ablon, Ava Shamban, Susan Weinkle, Jessica Brown, Yan Liu, Ablon Skin Institute, Manhattan Beach, CA; Ava MD, Santa Monica & Beverly Hills, CA; Susan H. Weinkle, MD, Bradenton, FL; Revance Therapeutics, Newark, CA
About Revance Therapeutics, Inc.
Revance Therapeutics, Inc. is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection. DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing U.S. regulatory approval. Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity. To accompany DaxibotulinumtoxinA for Injection, Revance owns a unique portfolio of premium products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA® Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the HintMD fintech platform, which includes integrated smart payment, subscription and loyalty digital services. Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to BOTOX®, which would compete in the existing short-acting neuromodulator marketplace. Revance is dedicated to making a difference by transforming patient experiences. For more information or to join our team visit us at www.revance.com.
"Revance Therapeutics" and the Revance logo are registered trademarks of Revance Therapeutics, Inc.
Resilient Hyaluronic Acid® and RHA® are trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
Forward-Looking Statements
Any statements in this press release that are not statements of historical fact, including statements related to our ability to obtain, and the timing relating to the anticipated approval of DaxibotulinumtoxinA for Injection in glabellar lines; the results of the SAKURA Phase 3 clinical program; development of a biosimilar to BOTOX®; statements about our business strategy, timeline, other goals and our plans and prospects; and potential benefits of our drug product candidates and our technologies, 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: the results, timing, costs, and completion of our research and development activities and regulatory approvals, including delays in the approval of our BLA for DaxibotulinumtoxinA for Injection for the treatment of glabellar lines; the impact of the COVID-19 pandemic on our manufacturing operations, supply chain, end user demand for our products, commercialization efforts, business operations, clinical trials and other aspects of our business; our ability to manufacture supplies for our product candidates; the uncertain clinical development process; the risk that clinical trials may not have an effective design or generate positive results; the applicability of clinical study results to actual outcomes; our ability to successfully compete with other treatments and therapies; our ability to achieve, and the rate and degree of commercial acceptance and the market, size and growth potential of our drug product candidates, if approved; our ability to successfully commercialize our drug product candidates, if approved, and the timing and cost of commercialization activities; our ability to obtain and maintain regulatory approval of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; our ability to develop sales and marketing capabilities; the status of commercial collaborations; our ability to obtain funding for our operations; 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 25, 2021. 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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FAQ
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