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.
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New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.
Fourteen medicines that are in the final stages of the evaluation process at the European Medicines Agency should find out this week whether they will be approved for marketing across the EU.
Genentech overcame objections from US FDA quality reviewers to win approval of Ocrevus for multiple sclerosis by adding release and stability testing and committing to resolving process control issues, while suspending plans to accelerate post-approval manufacturing changes.