Revance Therapeutics announces BLA acceptance for their long-acting neuromodulator, DaxibotulinumtoxinA (DAXI), with an action date set for November 25, 2020.
Revance Therapeutics, a biotechnologycompany focused on aesthetic innovation, recently announced that their neuromodulator, DaxibotulinumtoxinA (DAXI), has been accepted for review by the U.S. Food and Drug Administration (FDA) Biologics License application (BLA) for use in moderate to severe glabellar lines.
DAXI has been studied in three phase 3 clinical trials. It combines a “proprietary stabilizing peptide excipient with a highly purified botulinum toxin without human or animal-based components.”
Median results from the trials show DAXI is long lasting.
“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,”according to the press release.
Along with its use for glabellar lines, DAXI is being evaluated for its use in forehead lines and crow’s feet, as well as for therapeutic use in cervical dystonia, adult upper limb spasticity and plantar fasciitis with future plans to study it for migraine treatment.
In the acceptance letter, the FDA stated that there were no potential filling issues with the application and no plans to hold an advisory committee for discussion.
They have set the action date for November 25, 2020, under the Prescription Drug User Fee Act (PDUFA) VI program, according to the release.
“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, in the release. “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.”
The acceptance comes just a month after the company’s announcement of a U.S. distribution agreement with Swiss manufacturing company, TEOXANE SA, for their Resilient Hyaluronic Acid® (RHA®) dermal fillers. Reported by Dermatology Times, the agreement gives the company sole commercial access to TEOXANE’s RHA fillers in the U.S. market.