Resources for Food and Drug Administration (FDA)

Accentia starts FDA approval process for MS treatment

charlotte.bizjournals.com

Accentia Biopharmaceuticals Inc. filed a preliminary Investigational New Drug application for the U.S. Food and Drug Administration for Revimmune, for the treatment of multiple sclerosis. The company said in a release it has asked for a meeting with the FDA in the next 60 days to talk about a proposed Phase 3 clinical trial involving about 270 patients with relapsing/remitting MS.

The trial would determine if Revimmune improves function and reverses disability, the release said. Accentia said no other approved therapy for MS has shown a recovery of neurologic function, and the company's proposal to use the restoration of neurologic function as the endpoint would be the first filed with the FDA.

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