Encouraging news has come from Santhera Pharmaceuticals and ReveraGen BioPharma – the U.S. Food and Drug Administration (FDA) has accepted the new drug application for vamorolone to treat Duchenne muscular dystrophy and has set October 26, 2023, as the target date to complete its review.

“This is an exciting time for the Duchenne community as the data generated across the clinical trial program indicate that vamorolone has the potential to address relevant aspects in patient care that could also enhance treatment outcomes.

If approved, vamorolone will emerge as an additional treatment option in current standards of care in DMD, with the potential to address unmet medical needs and treat a majority of Duchenne patients starting at an early age.”

Eric Hoffman, Ph.D., President and CEO of ReveraGen BioPharma

Defeat Duchenne Canada has granted $1 million to Dr. Hoffman for this project and the vamorolone clinical trials in Canada. We are encouraged by the response of the FDA and will continue to work with Santhera in bringing this treatment to the Canadian Duchenne community.

Please see the full press release below: