Revance Therapeutics, Inc., a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the 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 stabilised with Peptide Exchange Technology™ (PXT) and is free of both human serum albumin and animal-based components. DAXXIFY™ also has the ability to address duration of treatment effect, which they believe is the greatest unmet need with existing neuromodulators for both consumers and injectors.
The FDA approval, Revance’s first, augments the company’s aesthetics portfolio and expands its access to the growing $3.2 billion U.S. facial injectables market, further establishing Revance as a 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 realise 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.
The U.S. approval of DAXXIFY™ was based on the data generated in the SAKURA Phase 3 clinical trial programme, which included more than 2,700 patients and approximately 4,200 treatments.