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Santhera and ReveraGen: Successful FDA Pre-NDA Meeting for Vamorolone

novembre 18, 2021

Defeat Duchenne Canada is pleased to share that Santhera Pharmaceuticals and ReveraGen BioPharma have reached an important regulatory milestone for Vamorolone with the U.S. Food and Drug Administration (FDA).

There was a successful pre-New Drug Application (NDA) meeting to obtain agreement from the FDA on the sufficiency and adequacy of the clinical data to support an NDA filing of Vamorolone for the treatment of Duchenne muscular dystrophy. Acceptance of the NDA will be subject to the FDA’s review of the complete filing. If they are successful with an FDA approval, we hope this will bring us one step closer to a possible filing in Canada. In the meantime, clinical trials for Vamorolone are scheduled to begin in Canada in the first quarter of 2022.

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