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# Santhera Pharma Delays NDA Over Inspection Readiness
- URL: https://www.fdaweb.com/santhera-pharma-delays-nda-over-inspection-readiness/
- Published: 2022-06-29T12:00:00.000Z
- Updated: 2026-09-14T17:50:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152201

Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy (DMD) has been postponed by four to six months after a third-party contract manufacturing organization (CMO) communicated a delay in reaching FDA-inspection readiness. The completed rolling NDA is now expected sometime in the fourth quarter.

The company says it began submitting the rolling NDA modules in March and it just submitted the clinical module recently. “Formal confirmation of inspection readiness by the CMO is a prerequisite for the FDA to consider a filing complete and to accept an NDA for review,” it says. “Therefore, Santhera will discuss with the agency the status and updated timelines for completing the NDA filing by Q4-2022.”

Vamorolone works by binding to the same receptor as corticosteroids but “modifies its downstream activity and as such is considered a dissociative anti-inflammatory drug,” the company says. “This mechanism has the potential to ‘dissociate’ efficacy from typical steroid safety concerns and therefore vamorolone could emerge as a promising alternative to existing corticosteroids, the current standard of care in children and adolescents with DMD.”