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Roche’s Ocrevus shows benefits in new clinical trials
Roche has announced the publication of new data from three phase III clinical trials that demonstrate the safety and efficacy of its investigational multiple sclerosis drug Ocrevus.
Published in the New England Journal of Medicine, the results from the OPERA I and OPERA II studies showed Ocrevus' benefits in the treatment of relapsing multiple sclerosis (RMS), while the ORATORIO study focused on primary progressive multiple sclerosis (PPMS).
Findings from these three studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with an established treatment option across both forms of the disease.
The primary endpoint was met in all of the studies, which included relative reduction of annualised relapse rate in the RMS trials and reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study.
Key secondary endpoints were also met, including multiple measures of disability progression and brain lesion activity. Data from these trials will be used to support ongoing regulatory filings for Ocrevus.
Dr Xavier Montalban, professor of neurology and neuroimmunology at Vall d'Hebron University Hospital, said: "Over the last decade, other molecules have tried and failed to demonstrate efficacy for PPMS, so the positive results for Ocrevus mark an important step in our understanding of this highly disabling form of the disease."
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