Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Injection for Glabellar Lines
21 April 2022 - - The US Food and Drug Administration has accepted US-based biotechnology company Revance Therapeutics, Inc's (NASDAQ: RVNC) Biologics License Application resubmission for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines, the company said.

The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the company's manufacturing facility.

Revance was provided a Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022.

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

Revance has successfully completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar (frown) lines, for which the company is currently pursuing US regulatory approval, and in cervical dystonia.

Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity. Revance owns a unique portfolio of premium products and services for US aesthetics practices, including the exclusive US distribution rights to the RHA Collection of dermal fillers, the first and only range of FDA-approved fillers for correction of dynamic facial wrinkles and folds, and the OPUL Relational Commerce Platform.

Revance has also partnered with Viatris (formerly Mylan N.V.) to develop a biosimilar to Botox, which if approved, would be the first and only generic biosimilar to Botox and Botox Cosmetic.