FDA Accepts Resubmitted BLA for Cosmetic Therapy

The new PDUFA date for is Sept. 8, 2022, for daxibotulinumtoxinA, Revance’s therapy to treat frown lines.

The FDA has accepted Revance Therapeutics’s resubmission of the biologics license application of daxibotulinumtoxinA injection to treat moderate-to-severe glabellar (frown) lines. 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.

The FDA had issued a complete response letter for daxibotulinumtoxinA in October 2021. At the time, the regulatory agency had indicated that there were deficiencies related to the FDA’s onsite inspection at Revance’s manufacturing facility. Specifically, the company needed to quality its new working cell bank (WCB) by producing three consecutive drug substance lots and one drug product lot.

Revance resubmitted the application in March and indicated that they had completed the production of required drug substance lots and drug product.

DaxibotulinumtoxinA combines Revance’s stabilizing peptide excipient with a purified botulinum toxin that does not contain human or animal-based components. The results of two clinical trials, published in the Journal of Plastic and Reconstructive Surgery in January 2020, found that daxibotulinumtoxinA achieved a benefit of at least 24 weeks for frown lines and provided a more prolonged clinical benefit than would be anticipated from initial treatment with any of the currently available botulinum toxin type As.