Santhera and ReveraGen Complete NDA Submission to FDA for Vamorolone in Duchenne Muscular Dystrophy 

 Pratteln, Switzerland, and Rockville, MD, USA, October 27, 2022 – Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that they have completed the rolling submission of a new drug application (NDA) to the U.S. Food and Drug Administration (FDA), seeking priority review for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). Subject to approval, vamorolone is set to become available to patients in the U.S. in H2-2023. 

 At the core of the NDA submission are positive data from the pivotal Phase 2b VISION-DMD study which comprised (1) a 24-week period to demonstrate efficacy and safety of vamorolone (2 and 6 mg/kg/day) versus prednisone (0.75 mg/kg/day) and placebo, followed by (2) a 24-week period to evaluate the maintenance of efficacy and collect additional longer-term safety and tolerability data [1]. In addition, the filings include data from four open-label studies (including extension) in which vamorolone was administered at doses between 2 and 6 mg/kg/day for a total treatment period of up to 30 months [2] and an external comparator study…


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