Revance to Showcase Clinical Findings at The Aesthetic Meeting 2021 that Supports DaxibotulinumtoxinA’s 24-Week Long Duration Profile Across Multiple Female Age Cohorts
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
The abstracts are available online via the ASAPS website at surgery.org.
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
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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.
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