Revance Receives FDA Acceptance of License Application for Frown Line Treatment

Revance Therapeutics (NASDAQ:RVNC) announced that the Biologics License Application (BLA) for its treatment of frown lines has been accepted for review by the US Food and Drug Administration (FDA).

As quoted in the press release:

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.

“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.”

Click here to read the full press release.