Roche's MS drug Ocrevus approved in Europe
Roche announced Friday that the European Commission approved Ocrevus (ocrelizumab) for patients with active relapsing forms of multiple sclerosis (RMS) and for those with early primary progressive multiple sclerosis (PPMS). The company noted that Ocrevus is the first approved disease-modifying medicine in the EU for patients with early PPMS, as well as an "important new treatment option for people with active RMS that significantly suppressed three major markers of disease activity and disability progression compared with [Merck KGaA's] Rebif (interferon beta-1a)."
European approval was supported by data from three Phase III studies from the ORCHESTRA clinical trial programme involving a total of 2388 patients. In the OPERA I and OPERA II studies, Ocrevus significantly reduced the annualised relapse rate over a two-year period versus Rebif in patients with RMS. Meanwhile, in the ORATORIO trial of patients with PPMS, the therapy significantly slowed the progression of clinical disability versus placebo.
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.
Ocrevus, a humanised monoclonal antibody designed to selectively target CD20-positive B cells, was cleared by the FDA last March for both relapsing and primary progressive forms of MS. At the time, Roche said it would set the drug's price at $65 000 per year, representing a 25-percent discount to Rebif.
For related analysis, see ViewPoints: Ocrevus latest drug blindsided by unverified reports in FAERS – will it have any impact?