Manufacturing questions delay yet another FDA drug approval in 2016

Manufacturing issues have pushed the expected approval of Roche’s experimental drug for multiple sclerosis to next year, bringing to six this year the number of drugs whose approvals by the FDA have been delayed because of questions over production.Tuesday Roche reported the PDUFA date for Ocrevus had been pushed back three months to March 28 from its original Dec. 28, 2016 date. Roche is seeking a license for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus was fast-tracked by the FDA in June and at one point, the Swiss company said it might have the drug on the market by year-end. Roche said the delay was not tied to the efficacy or safety of the treatment for the humanized monoclonal antibody is a sterile drug which is given by intravenous infusion every 6 months. Instead the extension is the result of the additional data provided to the FDA about Roche’s commercial manufacturing process which was is going to take the FDA time to digest.