Blog Big Molecule Watch December 03, 2020

COVID-19 Delays FDA-Approval of DaxibotulinumtoxinA

Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection biologic.  A letter from the FDA indicated that there were no other issues with the DaxibotulinumtoxinA BLA, but that the BLA approval process requires an inspection of the manufacturing facilities.  We have previously reported on FDA delays related to COVID-19 travel restrictions

DaxibotulinumtoxinA is an investigational neuromodulator product, combining a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components for the treatment of moderate to severe glabellar (frown) lines.  In additional to its use in facial aesthetics, DaxibotulinumtoxinA is also currently being evaluated in Phase 3 trials for the treatment of cervical dystonia, and in Phase 2 trials for the treatment of limb spasticity.  Revance Therapeutics, Inc. is a California biotechnology company focusing on aesthetic and therapeutic products.

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