Revance Announces U.S. FDA Acceptance of Supplemental Biologics License Application for Daxxify (Daxibotulinumtoxina-Lanm) for Injection for the Treatment of Cervical Dystonia
January 06, 2023
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Revance Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for DAXXIFY® (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults, a chronic and debilitating neurologic condition affecting the muscles of the neck.1 Revance was provided a Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.
DAXXIFY®, the first and only peptide formulated neuromodulator, which was approved by the FDA for the temporary improvement of moderate to severe glabellar lines in adults, was evaluated in two Phase 3 clinical studies for cervical dystonia: ASPEN-1, a randomized, double-blind, placebo-controlled, parallel group trial, and ASPEN-OLS, an open-label, repeat dose, long-term safety trial. In the pivotal ASPEN clinical program, DAXXIFY® was shown to be effective, generally safe and well tolerated
across both dose groups, 125U and 250U, and clinically meaningful improvement was observed by both patients and clinicians, compared to placebo, with a median duration of effect of 24.0 and 20.3 weeks, for the two dose
groups respectively. Results from the ASPEN-OLS study reinforced the safety findings reported from ASPEN-1
study, as well as the efficacy of DAXXIFY® with up to four repeat treatments. The FDA's acceptance of the company's sBLA advances Revance's opportunity in the nearly $1.0 billion, U.S.
muscle movement disorder market, which includes both cervical dystonia and spasticity.
Revance Therapeutics, Inc. is a biotechnology company focused on developing and commercializing aesthetic and therapeutic offerings. The Company's portfolio includes DAXXIFY (DaxibotulinumtoxinA-lanm) for injection and the RHA Collection of dermal fillers in the United States. It has also partnered with Viatris to develop a biosimilar to onabotulinumtoxinA for injection and Fosun to commercialize DAXXIFY in China. Its product/product candidate includes DAXXIFY for glabellar lines indication; DAXXIFY for cervical dystonia indication; RHA Redensity for perioral rhytids indication; RHA 2/ RHA 3/ RHA 4 for facial wrinkles and folds (such as nasolabial folds) indication; DAXXIFY for forehead lines, lateral canthal lines, upper facial lines indication; DAXXIFY for upper limb spasticity indication, and onabotulinumtoxinA biosimilar. The Company has exclusive right to import, market, promote, sell and distribute Teoxane's line of Resilient Hyaluronic Acid dermal fillers.
Revance Announces U.S. FDA Acceptance of Supplemental Biologics License Application for Daxxify (Daxibotulinumtoxina-Lanm) for Injection for the Treatment of Cervical Dystonia