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Ocrelizumab effective in people with primary progressive MS

9/28/2015

The Phase III ORATORIO study showed treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo in patients with primary progressive multiple sclerosis, as measured by the Expanded Disability Status. Genentech will submit data to the U.S. Food and Drug Administration for both forms of multiple sclerosis in early 2016.

Genentech plans to pursue marketing authorization for ocrelizumab in relapsing MS and in PPMS. Data from the OPERA I and II studies and from the ORATORIO study will be submitted to the U.S. Food and Drug Administration in early 2016.

ORATORIO is a Phase III, randomized, double-blind, global multicenter study evaluating the effectiveness and safety of ocrelizumab (600 mg administered by intravenous infusion every six months; given as two 300 mg infusions two weeks apart) compared with placebo in 732 people with PPMS. The primary endpoint of the ORATORIO study was time to onset of confirmed disability progression, defined as an increase in EDSS that is sustained for at least 12 weeks.

“People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease, and there are no approved treatments for this debilitating condition," said Dr. Sandra Horning, chief medical officer and head of Global Product Development. “Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS.”



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