US FDA and EMA accept supplemental filings for Ocrevus

The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency has validated the application for a two-hour Ocrevus (ocrelizumab) infusion time, dosed twice-yearly for relapsing or primary progressive multiple sclerosis (MS) that have been submitted by Swiss pharma giant Roche (ROG: SIX).

“With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90% of patients continuing with treatment through one year,” said Dr Levi Garraway, Roche’s chief medical officer, adding: “We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”

Ocrevus is already the multiple sclerosis (MS) market leader in its class, recording sales of around $3.7 billion in 2019. By 2025, annual sales of the drug will reach $6.8 billion, according to the data and analytics company GlobalData.

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