FDA Review of Multiple Sclerosis Drug Extended

FDA extends biologics license application review for MS drug ocrelizumab (Ocrevus) to allow for more information on manufacturing process.

Roche recently announced that the FDA has extended its review of the biologics license application for ocrelizumab (Ocrevus) to treat patients with multiple sclerosis (MS). The new date under the Prescription Drug User Fee Act is now March 28, 2017.

The resulting extension is due to Roche supplying the agency with additional information regarding the manufacturing process of the drug, according to a company press release.

The extension is not due to any efficacy or safety issues with ocrelizumab, and Roche believes that the drug will provide a novel treatment option for patients with MS.

Ocrelizumab is an investigational, humanized monoclonal antibody that selectively targets CD20-postive B cells, Roche reported. This type of immune cell is thought to be a main factor in myelin and axonal damage that can cause disability in patients with MS.

Preclinical trials have shown that ocrelizumab can bind to CD20 cell surface proteins that are expressed on B cells, and may protect important immune cell functions, since stem and plasma cells are not harmed, according to the press release.

Roche filed a biologics license application for ocrelizumab based on the positive findings from the OPERA I, OPERA II, and ORATIO phase 3 clinical trials.

OPERA I and OPERA II are identical studies that tested the efficacy and safety of ocrelizumab administered via infusion every 6 months, compared with 3 weekly injections of interferon beta-1a. The studies included 1656 patients with relapsing forms of MS.

Ocrelizumab also increased the amount of patients achieving no evidence of disease activity by 33% within the first 24 weeks of treatment, and 72% in weeks 24 to 96 compared with inferno beta-1a, Roche reported. Approximately 60.8% and 72.2% of patients achieved no evidence of disease activity within the first 24 weeks, and weeks 24 to 96, respectively.

ORATIO also evaluated the safety of ocrelizumab (600 mg administered intravenously every 6 months; given as two 300 mg infusions 2 weeks apart) compared with placebo in 732 patients with primary progressive MS, according to the press release.

The FDA previously granted ocrelizumab priority review designation since the drug could potentially treat 95% of patients with MS. It was also previously granted breakthrough therapy designation for the treatment of primary progressive multiple sclerosis.

“We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS)," said Sandra Horning, MD, chief medical officer and head of Global Product Development of Roche. “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.”