Genentech and Roche announced that the Food and Drug Administration has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (Ocrevus™) for the treatment of people with PPMS. Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening disease and for which preliminary clinical evidence suggests that the drug may demonstrate substantial improvement over existing therapies. Remember that PPMS has no approved therapies.
Breakthrough Therapy Designation was granted to ocrelizumab based on positive results form a pivotal Phase III study (called ORATORIO) which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo in patients with PPMS. Top-line results were of ORATORIO were presented at the 31th ECTRIMS conference in October 2015.
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