Manufacturing questions delay yet another FDA drug approval in 2016

FDA consideration of the applications for Roche's experimental MS drug Ocrevus has been delayed while the agency looks over manufacturing data.

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. 

“We are working closely with the FDA during their review and committed to bringing this innovative medicine to the over 400,000 people with MS in the US living with this disabling disease as quickly as possible,” the company said in its statement.

This delay is different than the other five, all of which came in the form of complete response letters to drugmakers about concerns the FDA had over manufacturing. In fact, of the 12 CRLs the FDA issued this year, 5 were directly tied to manufacturing, accounting for more than 40% of the missives. In 2014 and 2015, the FDA issued only one CRL each year tied to manufacturing concerns.

In one of the 5 cases involving CRLs, the drugmaker and its contractor were able to respond quickly and get the drug approved yet this year, but the other four have led to delayed approvals and launches. That group includes Sanofi and Regeneron’s experimental IL-6 inhibitor sarilumab, an expected blockbuster that will compete with AbbVie’s Humira.

Ocrevus is one of the new drugs Roche is counting on to counter competition as its top-selling cancer drugs face a slew of biosimilars. FierceBiotech reported that sales for the treatment, which would for the first time be able to cover 95% of all MS sufferers, could range from $3 billion to $7 billion at peak. Novartis, Biogen, German Merck, Sanofi, Teva and others all have MS treatments on the market but none of those are currently approved for the progressive form of the disease, which makes up around 10% to 15% of all MS patients.