Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

 Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

Santhera and ReveraGen Report Results of Vamorolone in P-IIb VISION-DMD Study for Duchenne Muscular Dystrophy

Shots:

  • The P-IIb VISION-DMD study involves assessing the efficacy & safety of vamorolone (2&6 mg/kg/day) vs PBO and prednisone (0.75 mg/kg/day) in 121 ambulant boys aged 4 to <7 years with DMD for 48 wks.
  • The study met its 1EP i.e improvement in TTSTAND velocity, following the 1st period @24 wks. The 2 EPs include 6MWT & TTRW also showed significance over PBO, the therapy showed a favorable safety and tolerability profile over prednisone
  • The company plans to file an NDA with the US FDA in Q1’22 and plans to commercialize the therapy in the US & the EU following the approval. The company has requested the PR based on the FTD granted by the FDA

Click here to­ read full press release/ article | Ref: Santhera | Image: Business Wire

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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