Revance Therapeutics Inc has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for DaxibotulinumtoxinA for Injection (DAXI) in the treatment of moderate to severe glabellar (frown) lines, it announces in a media release.
The submission includes results from the SAKURA Phase 3 trials, which is the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar frown lines.
“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 media release.
“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,” he adds.
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 2019 Annual Meeting and published in Plastic and Reconstructive Surgery as well as accepted for future publication in the Journal of the American Academy of Dermatology.
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.
[Source: Revance Therapeutics Inc]