Santhera Reports the MAA Submission to the MHRA for Vamorolone to Treat Duchenne Muscular Dystrophy
- A MAA for vamorolone to treat DMD has been submitted by the company to the MHRA. The MAA submission was based on the P-IIb study (VISION-DMD) evaluating vamorolone (2/6mg/kg/day) vs PBO and prednisone (0.75mg/kg/day), followed by 24wk. period
- The filing also includes the results from the 3 open-label studies of vamorolone for ~30mos. The (VISION-DMD) study met its 1EPs of Time to Stand (TTSTAND) velocity vs PBO @24wks. and showed a good safety & tolerability profile
- The NDA approval of vamorolone in DMD is expected on Oct 2023 while the MAA is under EMA review with expected approval in late 2023. The company plans to launch vamorolone in both the US and the EU in Q4’23
Ref: Santhera | Image: Santhera
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