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Updates on ongoing NDA submission for vamorolone in Duchenne muscular dystrophy.- Santhera Pharma

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Published:30th Jun 2022

Santhera Pharmaceuticals announces that the clinical module of its rolling new drug application (NDA) for vamorolone in Duchenne muscular dystrophy (DMD) has been submitted to the FDA.


Finalization of the NDA submission to start the FDA official review is postponed by 4-6 months to Q4-2022 after a third-party contract manufacturing organization (CMO) communicated a delay in establishing FDA-inspection readiness.

Santhera commenced the NDA filing as a rolling submission in March 2022 following a successful pre-NDA meeting with the FDA. In its conclusions from this meeting, the FDA considered the proposed clinical efficacy and safety data sufficient to support an NDA filing of vamorolone for the treatment of DMD. The rolling submission has been proceeding according to plan with the clinical module submitted on June 28, 2022.

Condition: Duchenne Muscular Dystrophy
Type: drug

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