FDA defers approval of DaxibotulinumtoxinA for Injection in glabellar lines due to Covid-19 related travel restrictions

Revance Therapeutics announced that the United States (U.S.) Food and Drug Administration (FDA) has deferred a decision on the Biologics License Application (BLA) for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines.

In a communication received on November 24, 2020, the FDA reiterated that an inspection of the company’s manufacturing facility is required as part of the BLA approval process. The Agency was unable to conduct a required inspection of the company’s Northern California manufacturing facility due to the Agency’s travel restrictions associated with the COVID-19 pandemic. Revance confirmed with the FDA that their communication was not a Complete Response Letter.

Though the company’s BLA is still under review, the FDA did not indicate there are any other review issues at this time, beyond the on-site inspection. The FDA stated they are actively working to define an approach for scheduling outstanding inspections, once safe travel may resume and based on public health need and other factors.

“We appreciate FDA’s engagement on the Chemistry, Manufacturing and Controls (CMC), non-clinical, clinical and labeling sections of our BLA, particularly given the unique and unprecedented situation we are in as a result of the COVID-19 pandemic. We look forward to continued interaction with the Agency and remain ready to support FDA’s pre-approval inspection as soon as possible. We are fortunate that we manufacture our product at a single location in the U.S., which should put us at an advantage compared to international manufacturing locations once travel resumes,” said Mark J. Foley, President and Chief Executive Officer. “As stated in our third quarter earnings, with the addition of the RHA® Collection of dermal fillers and acquisition of the HintMD fintech platform earlier this year, we believe the company is in an excellent position, both commercially and financially, to weather a change to the timing of this potential approval.”

DaxibotulinumtoxinA for Injection is an investigational agent that combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components. In the first quarter of 2020, Revance announced that the BLA for DaxibotulinumtoxinA for Injection had been accepted for review by the FDA and the company had been given a Prescription Drug User Fee Act (PDUFA) target action date of November 25, 2020. The submission was based on results from the largest aesthetic neuromodulator clinical program ever conducted for the treatment of glabellar (frown) lines, including the SAKURA 1, 2 and 3 Phase 3 clinical studies.