Revance announced that the FDA had accepted its BLA resubmission for DaxibotulinumtoxinA for Injection, designed to treat severe glabellar lines.
Revance Therapeutics, a biotechnology company focused on innovative aesthetic and therapeutic offerings, announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) resubmission for DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines.
The FDA designated the BLA as a Class 2 resubmission, which has a 6-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.
DaxibotulinumtoxinA for Injection is a long-acting neuromodulator product. Revance has completed Phase 3 clinical programs for DaxibotulinumtoxinA for Injection in glabellar lines, for which the company is currently pursuing U.S. regulatory approval, and in cervical dystonia.
Revance is also evaluating DaxibotulinumtoxinA for Injection in adult upper limb spasticity.
Revance owns a portfolio of products and services for U.S. aesthetics practices, including the exclusive U.S. distribution rights to the RHA Collection of dermal fillers, which are FDA-approved fillers to correct dynamic facial wrinkles and folds.
Revance has also partnered with Viatris to develop a biosimilar to Botox, which, if approved, would be the first and only generic biosimilar to Botox and Botox Cosmetic, according to the company.