Vamorolone NDA mid-cycle review meeting by FDA completed

Vamorolone NDA mid-cycle review meeting by FDA completed

Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the U.S. Food and Drug Administration (FDA) of the new drug application (NDA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD).

 At the recent mid-cycle review meeting, the FDA indicated that no significant review or safety concerns were noted up to that point in their ongoing review. The FDA re-affirmed its earlier decision to forgo an Advisory Committee Meeting. In addition, the FDA confirmed the PDUFA date of October 26, 2023, on which an approval decision on the vamorolone NDA is expected.

In Europe, the review of the marketing authorization application (MAA) for vamorolone by the European Medicines Agency (EMA) is on track. A CHMP opinion is expected in Q4-2023, followed by an approval decision by the European Commission (EC) in late 2023. In the UK, a corresponding MAA is under review by the Medicines and Healthcare products Regulatory Agency (MHRA). Subject to approvals, Santhera plans to launch vamorolone in both the U.S. and the EU in late 2023. 

Read the full press release here.

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