Roche disclosed Tuesday that the FDA has extended its review of a filing seeking approval of the investigational multiple sclerosis therapy Ocrevus (ocrelizumab) until March 28, 2017. The company said the extension was triggered by the submission of additional data regarding the commercial manufacturing process for Ocrevus and is not related to the drug's efficacy or safety.
"We strongly believe in the potential of Ocrevus as a new therapeutic option for both people with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis," commented Roche chief medical officer Sandra Horning, adding "we are working closely with the FDA during their review and are committed to bringing this innovative medicine to the over 400 000 people with multiple sclerosis in the US…as quickly as possible."
FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Roche's application seeking marketing authorisation of Ocrevus for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis was accepted by the FDA and the European Medicines Agency in June. The Swiss drugmaker noted that its submissions were supported by data from a clinical development programme demonstrating the superiority of Ocrevus against Merck KGaA's Rebif (interferon beta-1a) in the treatment of relapsing multiple sclerosis, as well as against placebo among patients with primary progressive multiple sclerosis.
Ocrevus, a humanised monoclonal antibody designed to selectively target CD20-positive B cells, was awarded breakthrough therapy status by the FDA for primary progressive multiple sclerosis in February. Meanwhile, Roche has said that an EU decision is not expected until the third quarter of 2017, as the drug did not benefit from the European Medicines Agency's accelerated review programme.
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