NASHVILLE, Tennessee – (BUSINESS WIRE) – Revance Therapeutics, Inc. (Nasdaq: RVNC), a biotechnology company specializing in innovative aesthetic and therapeutic offerings, today announced an upcoming presentation at the American Society for Aesthetic Plastic Surgery (ASAPS) Aesthetic Meeting 2021 , to be held at the Miami Beach Convention Center in Miami Beach, Florida from April 29 to May 3, 2021. The video presentation will include data from a subgroup analysis of the SAKURA Phase 3 clinical program demonstrating efficacy, duration and the safety of DaxibotulinumtoxinA for injection in adult women across multiple age cohorts after treatment for glabellar wrinkles.
DaxibotulinumtoxinA for Injection is a new botulinum toxin type A for which Revance is currently seeking FDA approval for the treatment of glabellar lineages (GL). It is generally believed that as age increases, the effectiveness of botulinum toxin decreases. This has been shown in multiple studies with current cosmetic botulinum toxin products. The subgroup analysis of the SAKURA phase 3 clinical program for glabellar lines (GL), which is the largest program for GL with more than 3000 subjects, examined the effects of DaxibotulinumtoxinA for Injection on GL in patients with more than 3000 subjects. women aged 18 to 45,> 45 to 45. 55 and> 55. Further analysis was performed on women under 65 and ≥ 65 years of age. Analysis data showed that DaxibotulinumtoxinA for Injection was safe, effective, and induced a median duration of no or mild loss of at least 24 weeks in all female age groups.
“We look forward to sharing the positive results of our Phase 3 SAKURA program at this year’s aesthetic meeting,” said Roman Rubio, Senior Vice President of Clinical Development at Revance. “The data demonstrate the duration of 24 weeks of DaxibotulinumtoxinA for injection regardless of age in women, in addition to its positive efficacy and safety parameters in each subgroup analyzed.”
The summaries are available online via the ASAPS website at surgery.org.
Title: DaxibotulinumtoxinA for Injection Demonstrates Consistent Efficacy, Duration and Safety in Women Regardless of Age: Subgroup Analysis of a Large Phase 3 Program (SAKURA)
Authors and affiliations: Glynis Ablon, Ava Shamban, Susan Weinkle, Jessica Brown, Yan Liu, Ablon Skin Institute, Manhattan Beach, California; Ava MD, Santa Monica and Beverly Hills, California; Susan H. Weinkle, MD, Bradenton, FL; Revance Therapeutics, Newark, California
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 components of human or animal origin. Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for injection in glabellar wrinkles (frowning) and is pursuing regulatory approval in the United States. Revance is also evaluating DaxibotulinumtoxinA for injection in the entire upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications: cervical dystonia and upper limb spasticity in adults. . To accompany DaxibotulinumtoxinA for Injection, Revance has a unique portfolio of premium products and services for US aesthetic practices, including exclusive US distribution rights to the RHA® collection of dermal fillers, the first and only line of filler products approved by the FDA for the correction of dynamic facial wrinkles and folds; and the Hint® fintech platform, which includes integrated digital smart payment, subscription and loyalty services. Revance has also partnered with Viatris (formerly Mylan NV) to develop a biosimilar of BOTOX®, which would compete in the existing market for short-acting neuromodulators. 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 registered trademarks of TEOXANE SA.
BOTOX® is a registered trademark of Allergan, Inc.
Any statements in this press release that are not statements of historical fact, including statements related to our ability to obtain, and the timing of the planned approval of DaxibotulinumtoxinA for injection into the glabellar lines; the results of the SAKURA Phase 3 clinical program; development of a biosimilar to BOTOX®; statements about our business strategy, schedule, other objectives, and plans and prospects; and the potential benefits of our drug candidates and 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 on 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 future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements will never be achieved or will occur.
Forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from our expectations. These risks and uncertainties relate to, 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, marketing efforts, business operations, clinical trials and other aspects of our business ; our ability to manufacture supplies for our product candidates; uncertain clinical development process; the risk that clinical trials may not be designed effectively or yield positive results; the applicability of clinical study results to actual results; our ability to compete successfully with other treatments and therapies; our ability to achieve, as well as the rate and degree of commercial acceptance and the market, the size and growth potential of our drug candidates, if approved; our ability to successfully market our drug candidates, if approved, as well as the timing and cost of marketing activities; our ability to obtain and maintain regulatory approval for our drug candidates; unforeseen costs or delays in research, development and commercialization efforts; our ability to develop sales and marketing skills; the status of commercial collaborations; our ability to obtain financing for our operations; and other risks. Detailed information about factors that could cause actual results to differ materially from results expressed or implied in the statements in this press release can be found in our periodic filings with the Securities and Exchange Commission (SEC), including the factors described. in the section titled “Risk Factors” on our Form 10-K filed with the SEC on February 25, 2021. The forward-looking statements contained in this press release speak only as of the date hereof. We disclaim any obligation to update these forward-looking statements.