Santhera Receives the EMA’s CHMP Positive Opinion of Agamree (vamorolone) for the Treatment of Duchenne Muscular Dystrophy
Shots:
- The EMA’s CHMP has adopted a positive opinion recommending approval of Agamree for DMD patients aged ≥4yrs. The EC’s decision is expected within ~2mos. The MAA will be valid in all 27 member states of the EU as well as Iceland, Liechtenstein & Norway
- The clinical evidence was based on the (VISION-DMD) study & 3 open-label studies of vamorolone (given at doses b/w 2 & 6mg/kg/day for ~30mos.) as well as (FOR-DMD) study & several clinical pharmacology studies
- In the (VISION-DMD) study, boys treated with vamorolone on avg. maintained growth similar to PBO & those with prednisone on avg. experienced growth stunting, patients were able to resume growing in height who switched from prednisone to vamorolone after 24wks. The product is expected to be available in Germany in Q1’24
Ref: Globenews Wire | Image: Santhera
Related News:- Santhera Entered into an Exclusive License and Collaboration Agreement with Catalyst Pharmaceuticals for Vamorolone
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