European Medicines Agency validates MAA for vamorolone in Duchenne muscular dystrophy
Santhera Pharmaceuticals announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD)
Validation confirms that the submission is complete and that the review by the EMA’s Committee for Medicinal Products for Human Use (CHMP) has begun. Santhera expects the CHMP to complete the review and issue an opinion regarding approval to EMA’s European Commission (EC) in late Q3-2023.
Subject to EC approval, expected later in 2023, vamorolone will receive marketing authorization in all member states of the European Union, as well as in Norway, Liechtenstein and Iceland.
In the U.S., Santhera and ReveraGen have just completed the submission of the new drug application (NDA) to the Food and Drug Administration (FDA), seeking priority review for vamorolone for the treatment of DMD. Subject to approval, this paves the way for a potential launch in H2-2023.
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