Biogen Receives the European Commission’s Approval for Skyclarys (omaveloxolone) to Treat Friedreich’s Ataxia (FA)
Shots:
- The approval was based on the results from the P-II (MOXle) clinical trial evaluating the safety & efficacy of Skyclarys vs PBO in patients with FA for a duration of 48wks. Skyclarys has been approved by the US FDA
- The results depicted an improve mFARS scores with Skyclarys vs PBO whereas the exploratory data showed that patients treated with Skyclarys had lower mFARS scores at 3yrs. vs matched natural history group
- Skyclarys (omaveloxolone) is an oral therapy to be administered QD for the treatment of FA in adults and adolescents aged ≥16yrs. that has earlier received and ODD, FTD & RPDD from the US FDA & ODD from the EMA
Ref: Biogen | Image: Biogen
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
