FDA Review of Santhera’s Vamorolone NDA Delayed Due to Manufacturing Standards

The FDA’s review of Santhera’s New Drug Application (NDA) for vamorolone has been delayed because the company’s third-party contract manufacturing organization (CMO) is unable to establish FDA-inspection readiness.

Santhera is seeking FDA’s approval of the investigational drug — a first-in-class synthetic steroid with anti-inflammatory properties — for patients with Duchenne muscular dystrophy.

A formal confirmation of inspection readiness by the CMO is a prerequisite for the FDA to consider the NDA filing complete and to accept it for review.

The FDA has granted vamorolone Orphan Drug status, as well as Fast Track and Rare Pediatric Disease designations.