Santhera and ReveraGen have submitted the New Drug Application (NDA) for vamorolone to the U.S. Food and Drug Administration this week. Earlier this month, they submitted a Marketing Authorization Application (MAA) to the European Medicines Agency for vamorolone as a potential treatment for DMD.
The Press Release contains more information about the filing completion, as well as remarks from Santhera Chief Executive Officer Dario Eklund and Dr. Eric Hoffman, the founder of ReveraGen BioPharma, partner in the clinical development of vamorolone.
As stated in the press release, Santhera and ReveraGen have requested FDA Priority Review of the NDA for vamorolone. Pending acceptance of that request, vamorolone could have an FDA review decision by mid-2023. If not granted Priority Review, review of the submission would be complete in the second half of 2023.
Earlier this month, Santhera and ReveraGen have also filed a Marketing Authorization Application (MAA) to the European Medicines Agency for vamorolone as a potential treatment for DMD. We will keep you informed about the status of both the FDA and EMA submissions over the coming months.
Vamorolone has been granted Orphan Drug status in the United States and the European Union. In the U.K., the Medicines and Healthcare Products Regulatory Agency (MHRA) has designated vamorolone with Promising Innovative Medicine status.