US-based biotechnology firm Revance Therapeutics has announced that the US Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for DAXI as a treatment for moderate to severe glabellar (frown) lines.
In its correspondence, the US FDA mentioned that no major filing review issues were identified.
The FDA has set a Prescription Drug User Fee Act (PDUFA) VI programme action date until 25 November 2020, while the agency has indicated they do not currently plan to hold an advisory committee meeting to discuss the BLA.
Revance Therapeutics president and CEO Mark Foley said: “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.
“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.”
According to the company, DAXI has been evaluated in three Phase III trials (SAKURA 1, 2, 3).
The clinical trial programme of DAXI is considered to be the largest aesthetic neuromodulator clinical study conducted so far for the treatment of glabellar (frown) lines.
In the Phase III pivotal trial, the median time to loss of none or mild wrinkle severity was approximately 24 weeks, while the median time to return to baseline wrinkle severity was about 28 weeks.
Revance noted that the company recently became the exclusive US commercialisation partner for TEOXANE SA’s Resilient Hyaluronic Acid (RHA) dermal fillers.