Revance Therapeutics’ Daxxify (daxibotulinumtoxinA-lanm) Receives the US FDA’s Approval as First Therapeutic Indication for Cervical Dystonia
Shots:
- The approval was based on the P-III program (ASPEN 1) & (ASPEN OLS) evaluating Daxxifyin incl. 382 patients and 1240 treatments across up to five inj. cycles over 88wk. Daxxify was shown to be effective in (ASPEN) study and was safe & well tolerated across both dose groups 125U and 250U with a median duration of effect of 24.0 & 20.3wks. for 2 dose groups
- In the (ASPEN OLS) study, symptoms continued to improve at doses ~300U, AEs remained low, and dysphagia rates (difficulty swallowing) remained low (2.7% for ASPEN-1) & (4.2% for ASPEN-OLS) thus supporting the safety profile of Daxxify
- Daxxify was approved in the US in Sept 2022 for adults with a temporary improvement of glabellar lines & received ODD for cervical dystonia in adults
Ref: Businesswire | Image: Revance
Related News:- Revance Submits Supplemental Biologics License Application for Daxxify to Treat Cervical Dystonia
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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.
