Revance Therapeutics, Inc. has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar lines.
Under the current Prescription Drug User Fee Agreement (PDUFA VI), the FDA has agreed to file acceptable applications within 60 days of receipt and to review the majority of BLAs within 10 months following the Day 60 filing date. Based on that timeline, Revance anticipates potential product approval in the second half of 2020.
“The submission of our BLA represents a significant milestone in the Company’s history and initiates our transition from a development company to a commercial organization. I’m incredibly excited about the opportunity to introduce the first truly novel advancement in neuromodulator products in over 30 years. We believe that a long-acting neuromodulator product will fill a significant, unmet need in both aesthetics and therapeutics and that the market is hungry for innovation,” says Mark Foley, President and Chief Executive Officer of Revance, in a news release. “As we manufacture our own product in the United States, the BLA filing represents a monumental achievement for a company of our size, which was only made possible through the incredible dedication and commitment of our employees.”
DAXI has been evaluated in three Phase 3 trials (SAKURA 1, 2, 3). Both SAKURA 1 and SAKURA 2 demonstrated that half of the patients treated maintained none or only mild frown lines for at least 24 weeks (approximately 6 months), after a single treatment. Additionally, frown lines did not return to their pre-treatment severity for at least 26–28 weeks for half of the patients treated. Results from the two pivotal Phase 3 trials, SAKURA 1 and SAKURA 2, were recently presented at the American Society for Dermatologic Surgery (ASDS) 2019 Annual Meeting and published in Plastic and Reconstructive Surgery (1 as well as accepted for future publication in the Journal of the American Academy of Dermatology.
“Based on the SAKURA trial results, DAXI has the potential to provide patients with lasting, natural-looking frown line correction all year long with just two treatments,” Foley adds.