Revance Announces FDA Approval of DAXXIFY™ (DaxibotulinumtoxinA-lanm) for Injection, the First and Only Peptide-Formulated Neuromodulator With Long-Lasting Results
Revance Therapeutics, Inc., (Nasdaq: RVNC), a biotechnology company focused on innovative aesthetic and therapeutic offerings, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved DAXXIFY™ (DaxibotulinumtoxinA-lanm) for injection for the temporary improvement of moderate to severe frown lines (glabellar lines) in adults.
DAXXIFY™ is the first and only neuromodulator stabilized with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components. Most importantly, DAXXIFY™ has the ability to address duration of treatment effect, which we believe is the greatest unmet need with existing neuromodulators for both consumers and injectors. The FDA approval, Revance’s first, augments the company’s innovative aesthetics portfolio and expands the company’s access to the growing $3.2 billion U.S. facial injectables market, further establishing Revance as an innovation leader in the industry and laying the groundwork for potential future therapeutic indications.
“The FDA approval of DAXXIFY™ is a foundational achievement for the company as it marks the culmination of years of pioneering research and development made possible by the outstanding execution of our talented team, along with strong support from the medical and investor communities. It has been an incredible and rewarding journey to realize our vision and bring this disruptive innovation to an industry that has remained largely unchanged for over 30 years,” said Mark J. Foley, Chief Executive Officer. “Importantly, we are very pleased DAXXIFY™’s label includes data demonstrating the achievement of none or mild wrinkle severity based on investigator and subject assessments, as this provides the foundation for our marketing claims around duration of effect. We look forward to continuing to set new standards in aesthetics and to establishing a new category of long-lasting, peptide-enhanced neuromodulators.
Jeffrey Dover, MD, co-director of SkinCare Physicians of Chestnut Hill, commented, “As a SAKURA investigator, I’m pleased to see DAXXIFY™ now approved as the first and only peptide-formulated, long-acting neuromodulator in the market. Compelling data from the largest Phase 3 clinical program ever conducted for glabellar lines demonstrated that DAXXIFY™ was well tolerated and achieved clinically significant improvement with long-lasting results and high patient satisfaction. Notably, DAXXIFY™ was able to demonstrate a long duration of effect while only utilizing 0.18 ng of core active ingredient in the 40-unit labeled indication for glabellar lines. With today’s approval, I look forward to helping patients, who have been accustomed to a 3 to 4-month duration profile with conventional neuromodulators, achieve year-long results with as few as two treatments per year.
The U.S. approval of DAXXIFY™ was based on the data generated in the SAKURA Phase 3 clinical trial program (SAKURA 1,2,3), which included more than 2,700 patients and approximately 4,200 treatments.
Published: Sep 09, 2022
