FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

FDA Postpones PDUFA for Roche’s MS Therapy Ocrevus to March

Jan. 3, 2017

The FDA has extended the PDUFA date for Roche’s multiple sclerosis candidate Ocrevus to March in order to review new manufacturing data submitted by the company.

The manufacturing data will require additional time for FDA review, the company said. The extension is not related to the efficacy or safety of Ocrevus.

Roche evaluated the safety and efficacy profile of Ocrevus in randomized, double-blind, double-Phase III trials.

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