PDUFA Review Date for Ocrelizumab for Multiple Sclerosis Extended Until March

Deborah Brauser

December 21, 2016

Although the Prescription Drug User Fee Act (PDUFA) date from the US Food and Drug Administration (FDA) for a hotly anticipated drug for multiple sclerosis (MS) was expected to come on December 28, the agency has decided to extend its review until the spring, the manufacturer reports.

According to a release from Roche, the review date of the Biologics License Application of ocrelizumab (Ocrevus) is now scheduled for March 28, 2017. The company added that the extension was based on their submission of additional manufacturing process data — and was not because of any questions about the safety or efficacy of the drug.

The humanized monoclonal antibody selectively targets CD20-positive B cells. Submission was based on results from the phase 3 ORATORIO trial of ocrelizumab vs placebo in primary progressive MS and from the identical phase 3 OPERA 1 and OPERA 2 trials of the treatment vs interferon β-1a in relapsing MS. Together, the 3 randomized controlled trials evaluated more than 2300 patients.

As reported by Medscape Medical News, preliminary results from the trials were presented at the 2015 Congress of the European Committee for Treatment and Research in MS (ECTRIMS) in Barcelona, Spain.

In addition, subgroup analysis from ORATORIO was presented at the Americas Committee for Treatment and Research in MS (ACTRIMS) Forum 2016, and NEDA (no evidence of disease activity) analysis from OPERA 1 and OPERA 2 were presented at the American Academy of Neurology (AAN) 2016 Annual Meeting.

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