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Roche: OCREVUS Shorter 2-hour Infusion Time For MS Gets Europe Approval

Swiss drug maker Roche (RHHBY) announced Thursday that the European Medicines Agency or EMA has approved a new, shorter two-hour OCREVUS (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis or MS.

The approval is based on a positive opinion from the EMA's Committee for Medicinal Products for Human Use or CHMP.

The approval is based on data from the randomised, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions or IRRs for a two-hour OCREVUS infusion time compared to the conventional 3.5-hour time in patients with relapsing-remitting MS.

The first dose was administered per the approved dosing schedule and the second or later doses were administered over a shorter, two-hour time.

The U.S. Food and Drug Administration has already accepted a supplemental Biologics License Application for a two-hour OCREVUS infusion time and is expected to make a decision by December 14.

Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development, said, "With more than 160,000 people treated with OCREVUS globally, a shorter infusion may assist both patients and healthcare providers to reach the ultimate goal of slowing disease progression in MS."

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