The European Commission (EC) has approved ocrelizumab (Ocrevus, Roche) for adults with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).
The action follows a recommendation for approval in November 2017 by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
The US Food and Drug Administration approved ocrelizumab for RMS and PPMS in March 2017.
Ocrelizumab is a humanized anti-CD20 monoclonal antibody that selectively targets CD20-expressing B cells. It is administered by intravenous infusion every 6 months. The initial dose is given as two 300-mg infusions given 2 weeks apart. Subsequent doses are given as single 600-mg infusions.
European approval is based on data from three phase 3 studies of 2388 patients “who met primary and nearly all key secondary endpoints,” Roche said in a news release.
Key findings from the two identical phase 3 studies in RMS, known as OPERA I and OPERA II, include the following:
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A 46% and 47% relative reduction in the annualized relapse rate compared with interferon β-1a over the 2-year period in OPERA I and OPERA II, respectively (both P < .0001).
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A 40% relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon β-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (P = .0006).
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A 94% and 95% relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon β-1a in OPERA I and OPERA II, respectively (both P < .0001).
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A 77% and 83% relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon β-1a in OPERA I and OPERA II, respectively (P < .0001).
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A 64% and 89% relative increase in the proportion of patients with no evidence of disease activity (NEDA) compared with interferon β-1a in OPERA I and OPERA II, respectively (P < .0001).
In the PPMS phase 3 study, patients treated with ocrelizumab were 24% less likely to have CDP for 3 months and 25% less likely to have CDP for 6 months (P = .0321 and P = .0365, respectively). Ocrelizumab also significantly slowed the progression of walking impairment by 29.4%, measured by the timed 25-foot walk, compared with placebo (P = .0404). In this study, a 3.4% reduction in volume of brain hyperintense T2 lesions was noted compared with a 7.4% increase in volume in placebo-treated patients over 120 weeks (P < .0001).
The most common side effects associated with ocrelizumab in phase 3 studies were infusion reactions and upper respiratory tract infections, which were mostly mild to moderate in severity.
Ocrevus “has the potential to be a significant game changer in how we think about and treat MS,” Gavin Giovannoni, MD, a neurology professor at Barts and The London School of Medicine and Dentistry in the United Kingdom, who has worked with Roche on studying the drug, said in a company news release.
MS affects about 700,000 people in Europe, of whom around 96,000 have the highly disabling primary progressive form.
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