Revance announces acceptance of BLA for daxibotulinumtoxinA
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Revance Therapeutics announced the biologics license application for daxibotulinumtoxinA for injection for the treatment of moderate to severe glabellar lines has been accepted for review by the FDA, according to a press release.
Evaluated in three phase 3 trials, daxibotulinumtoxinA for injection (DAXI) yielded a median time of 24 weeks for loss of none or mild wrinkle severity. The median time for return to baseline wrinkle severity was 28 weeks.
“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,” Mark Foley, president and CEO of Revance, said in the release. “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.”
A PDUFA date has been set for Nov. 25.