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Revance Therapeutics Says FDA Approves DAXXIFY For Injection To Treat Cervical Dystonia In Adults
(RTTNews) - Revance Therapeutics, Inc. (RVNC) announced Monday that the U.S. Food and Drug Administration (FDA) has approved the first therapeutic indication for DAXXIFY (DaxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia in adults.
The U.S. approval of DAXXIFY for the treatment of cervical dystonia in adults was based on data generated in the Phase 3 clinical program (ASPEN 1, ASPEN OLS), which included 382 patients and 1,240 treatments across up to five injection cycles over an 88-week time span, based on the masked, randomized ASPEN-1 and ASPEN Open Label Study (OLS).2-5 In the pivotal ASPEN clinical study,
Based on the ASPEN OLS study, symptoms continued to improve with successive DAXXIFY treatments at doses up to 300U, while adverse events remained low.
In 2017, the U.S. FDA granted orphan drug designation to DAXXIFY for the treatment of cervical dystonia in adults.
DAXXIFY, powered by Peptide Exchange Technology, was previously approved by the FDA for the temporary improvement of glabellar lines (frown lines) in adults in September 2022 and is the first true innovation in neuromodulator product formulation in more than 30 years.
Cervical dystonia is a chronic, debilitating disease in which the neck muscles contract involuntarily, causing abnormal movements, pain and awkward posture of the head and neck. Neuromodulators are considered the first line of treatment for this condition.
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