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US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time

Written by Customer Service on . Posted in Public Companies.

Reduces infusion time to 2 hours from the current 3.5 hours for patients with relapsing or primary progressive multiple sclerosis, if approvedApplications are based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the currently approved OCREVUS dosing regimen             
Basel, 20 April 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).AttachmentRoche_mediarelease Ocrevus_20042020 _EN

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