Roche’s Ocrelizumab Poised To Seize Primary Progressive MS Opportunity
This article was originally published in The Pink Sheet Daily
Roche plans to file the selective CD20 antibody in 2016 after releasing positive Phase III data at ECTRIMS in both relapsing-remitting and primary progressive multiple sclerosis, a debilitating form of the disease for which there are no approved drugs.
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Genentech’s ocrelizumab, a CD20-directed antibody, becomes first US-approved treatment for primary progressive multiple sclerosis and is also indicated for relapsing disease. Labeling includes warnings about infusion reactions, infections and malignancy but lacks a boxed warning or REMS.
US FDA extends review timeline for the multiple sclerosis BLA until March 28, 2017 to have time to review new information about commercial manufacturing process, Roche says.
Keeping Track: FDA Approves Epclusa, Designates Four Breakthrough Therapies, Files Burst Of Applications
The latest drug development news and highlights from our FDA Performance Tracker.