Ocrevus Launching Quickly Even After Manufacturing Worries Delayed US Approval

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.

Genentech Inc.’s multiple sclerosis therapy Ocrevus (ocrelizumab) will reach the US market in the next few weeks now that the Roche unit has overcome a regulatory hurdle that extended FDA’s review process.

On March 28, FDA approved ocrelizumab, a CD20-directed cytolytic antibody, for the treatment of patients with relapsing or primary progressive...

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