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FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis

Written by Customer Service on . Posted in Public Companies.

Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional OCREVUS dosing regimenShorter infusion time will further improve the twice-yearly treatment experience for OCREVUS, the only B-cell therapy for relapsing and primary progressive MS with a twice-yearly dosing scheduleBasel, 14 December 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) 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 was based on data from the randomised, double-blind ENSEMBLE PLUS study.
 Attachment14122020_MR_OCR shorter infusion FDA approval

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