Ocrevus (ocrelizumab) shorter infusion time application accepted

April 23, 2020
Genentech announced the U.S. Food and Drug Administration has accepted the company’s supplemental Biologics License Application 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.

The regulatory applications are based on data from the randomized, double-blind ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions for a two-hour Ocrevus infusion time vs. the currently approved 3.5-hour time in patients with relapsing-remitting MS. The first dose was administered per the approved dosing schedule (two 300 mg intravenous infusions separated by two weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, two-hour time. The primary endpoint of this study was the proportion of patients with IRRs following the first randomized 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). No patients discontinued the study because of an IRR and no new safety signals were detected.

Detailed data will be presented at the earliest opportunity. The FDA and the European Commission are expected to make decisions on these applications by the end of 2020.

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