Regulatory Agencies Consider 2-Hour Infusion Times for Ocrelizumab 

The US Food and Drug Administration (FDA) has accepted and will review a supplemental Biologics License Application (sBLA) for ocrelizumab (Ocrevus; Genentech, South San Francisco, CA) The European Medicines Agency (EMA) has also validated and will review the application for a 2-hour ocrelizumab infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).

“With more than 150,000 people treated with Ocrevus, the twice-yearly dosing schedule has benefited many MS patients and their physicians, as indicated by more than 90% of participants continuing with treatment through one year,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. “We hope a shorter infusion time will further improve the experience for people living with MS also increasing capacity in healthcare systems.”

The regulatory applications are based on data from the randomized double-blind Ensemble plus study (NCT03606460). Results of this study showed comparable safety, as measured by frequency and severity of infusion-related reactions (IRR), for a 2-hour vs 3.5 hour infusion time for ocrelizumab in individuals with relapsing-remitting MS (RRMS). The currently approved infusion time for ocrelizumab is 3.5 hours.. 

The first dose was administered per the approved dosing schedule (2 intravenous [IV] infusions of 300 mg separated by 2 weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, 2-hour time. The primary endpoint of this study was the proportion of individuals with IRRs following the first randomized 600 mg infusion (frequency/severity assessed during and 24-hours post-infusion). No participants discontinued the study due to an IRR and no new safety signals were detected.

With rapidly growing real-world experience and more than 150,000 participants treated globally, ocrelizumab has twice-yearly (6-monthly) dosing and is the first and only therapy approved for RMS (including relapsing-remitting MS [RRMS] and active, or relapsing, secondary progressive MS, in addition to clinically isolated syndrome in the US) and primary progressive MS (PPMS). 

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.