FDA reviewing sBLA for Daxxify in cervical dystonia.- Revance Therapeutics
Revance Therapeutics announced that the 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.
Revance was provided a Prescription Drug User Fee Act (PDUFA) date of August 19, 2023.
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.
Daxxify (daxibotulinumtoxinA-lanm) for injection is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
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