A Phase 3 clinical trial, called ORATORIO, evaluating Roche's investigational ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint of demonstrating reduced progression of clinical disability compared to placebo. The endpoint was defined as an increase in Expanded Disability Status Score (EDSS) that was sustained for at least 12 weeks. The incidence of serious adverse events was similar to placebo, most were infusion-related reactions. The results will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain on October 10 (Abstract #228).
Head of Global Product Development Sandra Horning, M.D., says, "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. Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in [PPMS]."
Roche intends to pursue marketing authorization for ocrelizumab in both relapsing MS and PPMS. Late-stage study data will be submitted to the FDA in early 2016. About 10% of MS patients have PPMS.
Related articles:
http://uk.reuters.com/article/2015/0...0RS1M720150928
http://www.reuters.com/article/2015/...0RS0KL20150928
Head of Global Product Development Sandra Horning, M.D., says, "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. Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in [PPMS]."
Roche intends to pursue marketing authorization for ocrelizumab in both relapsing MS and PPMS. Late-stage study data will be submitted to the FDA in early 2016. About 10% of MS patients have PPMS.
Related articles:
http://uk.reuters.com/article/2015/0...0RS1M720150928
http://www.reuters.com/article/2015/...0RS0KL20150928
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