Revance Therapeutics Inc announces that the Biologics License Application (BLA) for DAXI in the treatment of moderate to severe glabellar (frown) lines has been accepted for review by the US Food and Drug Administration (FDA).
In its correspondence, FDA stated that no potential filing review issues were identified. The FDA set an action date of November 25, 2020, under the Prescription Drug User Fee Act (PDUFA) VI program. The Agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application, a media release from Revance notes.
“The FDA’s acceptance of our BLA for our next-generation neuromodulator product, DAXI, is a significant achievement for Revance and a crucial step forward as we look to establish a new, premium, long-lasting neuromodulator category,” said Mark Foley, President and Chief Executive Officer of Revance.
“The patient experience has remained largely unchanged since botulinum toxin type A treatments were first introduced over 30 years ago. If approved, we expect that patients treated with DAXI may achieve lasting, natural-looking frown line correction all year long with as few as two treatments.”
DAXI has been evaluated in three Phase 3 trials, the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines. In the Phase 3 pivotal program, the median time to loss of none or mild wrinkle severity was 24 weeks and the median time to return to baseline wrinkle severity was approximately 28 weeks. 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 (PRS) (for Sakura 1) as well as in the Journal of the American Academy of Dermatology (JAAD) (for Sakura 2).
The BLA acceptance comes at the beginning of a potentially transformative year for Revance, as the company recently became the exclusive US commercialization partner for TEOXANE SA’s innovative Resilient Hyaluronic Acid (RHA) dermal fillers, which are highly complementary to DAXI.
Counting these two events, Revance has up to 12 significant clinical, regulatory and commercial milestones this year across both aesthetic and therapeutic indications. These include topline results from clinical trials utilizing DAXI for the treatment of forehead lines, lateral canthal lines (crow’s feet), full upper facial lines, cervical dystonia and plantar fasciitis, as well as completion of enrollment in an upper limb spasticity clinical study.
[Source: Revance Therapeutics Inc]