Despite Ocrelizumab Infection Risk, Roche Sees Multiple Sclerosis Opportunity
This article was originally published in The Pink Sheet Daily
Anti-CD20 molecule's future in RA was dashed by high infection risk, but Roche says the safety profile of ocrelizumab could be better in MS patients.
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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.
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.
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.