Vamorolone NDA mid-cycle review meeting for Duchenne muscular dystrophy by FDA completed
Santhera Pharmaceuticals and ReveraGen BioPharma, Inc announce the successful completion of the mid-cycle review meeting by the 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.
As part of the ongoing NDA review, the FDA conducted several inspections at various sites, including the contract manufacturer, the sponsor and certain clinical trial sites. All inspections to date were concluded with satisfactory outcomes.
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