FDA nod for shorter 2-hour infusion of Ocrevus for MS

The US Food and Drug Administration has approved a shorter two-hour infusion time for Ocrevus (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs).

The approval of Ocrevus, from Swiss pharma giant Roche (ROG: SIX), was based on data from the randomized, double-blind ENSEMBLE PLUS study.

“More than 170,000 people with MS have been treated with Ocrevus - the only approved B-cell therapy with a twice-yearly dosing schedule - and it is the most prescribed MS medicine in the US,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “We constantly strive to improve the experience that patients and their physicians have with our medicines, and we believe people with relapsing and primary progressive MS will find the shorter two-hour Ocrevus infusion time to be more convenient,” he noted.

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