Revance Submits Supplemental Biologics License Application for Daxxify to Treat Cervical Dystonia
Shots:
- The submission was based on the P-III (ASPEN-1) & (ASPEN-OLS) studies evaluating Daxxify in patients with cervical dystonia. The submission was followed by the approval of Daxxify by the US FDA for temporary improvement of moderate/severe glabellar lines in adults
- The results from the P-III (ASPEN-1) study showed the potential of Daxxify to reduce a 50% frequency of cervical dystonia treatments along with a median duration of effect of 24.0 & 20.3wks. for 125 & 250 Unit dose groups
- The result from the (ASPEN-OLS) study reinforced the long-term safety & efficacy of Daxxify from (ASPEN-1) with up to 4 consecutive treatments & a low incidence of dysphagia (1.6% vs 3.8%) & muscle weakness (4.8% vs 2.3%) for 125U & 250U in (ASPEN-1) vs (ASPEN-OLS)
Ref: Businesswire | Image: Revance
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