Santhera and ReveraGen have announced the initiation of a rolling new drug application (NDA) submission to the U.S. Food and Drug Administration (FDA) for vamorolone for the treatment of Duchenne. This is the first step in the process for moving towards a potential approval of the product.
The companies expect to complete the NDA filing in the second quarter of 2022. Based on FDA review timelines, notification from the FDA on the acceptance of the filing for review is expected in August 2022.
We look forward to additional updates as the rolling submission process continues.
Read the community letter from Santhera & Reveragen
Dear Duchenne community,
We are writing to provide an update on the status of the vamorolone program. Santhera Pharmaceuticals and ReveraGen BioPharma announced today that the submission of a rolling new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy has been initiated at the U.S. Food and Drug Administration (FDA). The submission initiation at FDA marks the first time that vamorolone for DMD has been filed in any market. Vamolorone is an investigational drug that has been granted Fast Track Designation by the FDA.
Santhera and ReveraGen had a successful pre-NDA meeting with the FDA in November of 2021 in which the agency considered the proposed clinical efficacy and safety data sufficient to support an NDA filing. Acceptance of the NDA will be subject to FDA’s review of the entire filing, which is expected to be complete in the second quarter of 2022. At the completion of the rolling NDA submission, Santhera and ReveraGen plan to request priority review from the FDA. If granted, priority review would set an anticipated approval date for as early as the first quarter of 2023. Subject to FDA approval, Santhera plans to launch vamorolone in the U.S. shortly thereafter.
In Europe, Santhera plans to submit a marketing authorization application (MAA) for vamorolone for the treatment of DMD to the European Medicines Agency (EMA) in Q3-2022. We will keep the Duchenne community informed of future regulatory events related to vamorolone in the EU, UK, and other global markets. For more information about today’s announcement, please see the press release from Santhera and ReveraGen here.
In closing, we would like to take this moment to express our deep appreciation to the families who participated in the development of vamorolone. As a company, Santhera is unyielding in our pursuit of treatments to slow the progression of Duchenne muscular dystrophy.
If you have any questions or if we can be of any further support, please do not hesitate to contact Mindy Cameron, our Global Patient Advocacy ambassador, at Mindy.Cameron@santhera.com
With warm regards,
Global Patient Advocacy and Government Affairs