Revance Submits Biologics License Application to the FDA for DAXI

Revance Therapeutics, Inc. announced it 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 frown lines and anticipates potential product approval in the second half of 2020.

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. Both SAKURA 1 and SAKURA 2 showed 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, and frown lines did not return to their pre-treatment severity for at least 26 to 28 weeks for half of the patients treated. “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,” says Mark Foley, president and CEO of Revance. “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. 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. Following this submission, Revance enters a catalyst-rich calendar year of significant clinical trial readouts and meaningful company milestones, which we believe will culminate in the approval and launch of DAXI in the aesthetic marketplace.”

RELATED STORIES

CD&R To Acquire Cynosure From Hologic

The Cellfina System Receives Five-Year FDA Indication

Galderma Announces Positive Phase 2 Results for its QM1114