Ocrelizumab May Represent Roche’s Rebound In Neuroscience
This article was originally published in The Pink Sheet Daily
Roche plans to file I.V. anti-CD20 antibody ocrelizumab in multiple sclerosis early in 2016, after disclosing that the drug met endpoints in two Phase III studies against Merck Serono’s Rebif.
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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.
Breakthrough program could speed first treatments for tardive dyskinesia, primary progressive multiple sclerosis, and Parkinson's psychosis to market, along with new fast-acting approaches to treatment-resistant depression.
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.