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Revance Submits Supplemental Biologics License Application for Daxxify to Treat Cervical Dystonia

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Revance Submits Supplemental Biologics License Application for Daxxify to Treat Cervical Dystonia

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  • 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

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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