Santhera’s Agamree (vamorolone) Receives EC’s Approval to Treat Duchenne Muscular Dystrophy
Shots:
- Followed by the positive opinion from the CHMP, the EC has granted approval to the Santhera’s Agamree (dosing b/w 2 and 6mg/kg/day, for total of 30mos.) for the treatment of DMD patients (aged 4yrs. & +) based on results from the (VISION-DMD) and 3 other trials
- The results showed that Agamree neither reduced bone metabolism nor bone mineralization in the spine after 48wks. and recovered growth & bone health after switching from prednisone. Further data is being collected for its efficacy and safety
- Additionally, Catalyst Pharmaceuticals holds an exclusive license for Agarmee in North America & expects the US launch in Q1’24. Santhera anticipates the drug’s launch in Germany during Q1’24
Ref: Santhera | Image: Santhera
Related News:- Santhera’s Agamree (vamorolone) Receives the US FDA’s Approval for the Treatment of Duchenne Muscular Dystrophy (DMD)
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
