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Santhera Reports the MAA Submission to the MHRA for Vamorolone to Treat Duchenne Muscular Dystrophy

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Santhera Reports the MAA Submission to the MHRA for Vamorolone to Treat Duchenne Muscular Dystrophy

Shots:

  • 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

Related News:- Santhera Collaborates with Sperogenix to Develop and Commercialize Vamorolone for Rare Diseases in the Greater China

Click here to­ read the full press release 

Senior Editor

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.

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