Research & Development
FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection
25 November 2020 - - The United States Food and Drug Administration has deferred a decision on the Biologics License Application for DaxibotulinumtoxinA for Injection, an investigational neuromodulator product for the treatment of moderate to severe glabellar (frown) lines, US-based biotechnology company Revance Therapeutics, Inc. (NASDAQ: RVNC) said.

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 said 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.

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 1Q20, 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.

Revance Therapeutics is a biotechnology company focused on innovative aesthetic and therapeutic offerings, including its next-generation neuromodulator product, DaxibotulinumtoxinA for Injection.

DaxibotulinumtoxinA for Injection combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components.

Revance has successfully completed a Phase 3 program for DaxibotulinumtoxinA for Injection in glabellar (frown) lines and is pursuing US regulatory approval.

Revance is also evaluating DaxibotulinumtoxinA for Injection in the full upper face, including glabellar lines, forehead lines and crow's feet, as well as in two therapeutic indications - cervical dystonia and adult upper limb spasticity.
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