BRIEF—Vamorolone submitted for US approval

Santhera Pharmaceuticals and ReveraGen BioPharma have started a rolling new drug application submission for vamorolone in the USA, after a successful pre-NDA meeting in late 2021.

The firms are seeking to market the Fast Track-designated therapy for Duchenne muscular dystrophy (DMD).

Swiss firm Santhera said the US Food and Drug Administration “considered the proposed clinical efficacy and safety data sufficient to support a New Drug Application (NDA) filing of vamorolone for the treatment of DMD.”

Acceptance of the NDA will be subject to FDA’s review of the complete filing, and a decision on whether to proceed is expected by August.

The FDA will also determine eligibility of vamorolone for Priority Review, which the firms plan to request upon completion of the rolling NDA submission.

Santhera plans to submit for European approval later this year, with a possible launch as early as the third quarter of 2022. The firm plans to launch in Germany first.