The FDA has accepted an sBLA for a version of Genentech’s ocrelizumab with a shorter administration time for the treatment of relapsing and primary progressive MS.
By: Matt Hoffman
Published: April 20, 2020
Levi Garraway, MD, PhDGenentech has announced that both the FDA and EMA have accepted supplemental applications for review for a new 2-hour ocrelizumab (Ocrevus) infusion that would be administered 2 times per year for those with relapsing or primary progressive multiple sclerosis (MS).
The supplemental biologics license application (sBLA) was accepted by the FDA based on data from the ENSEMBLE PLUS study, a double-blind, prospective substudy to the open-label, single-arm, phase 3b ENSEMBLE (NCT03085810) trial. The data suggest that the 2-hour infusion time has a comparable frequency and severity of infusion-related reactions (IRRs) to the currently approved 3.5-hour infusion time in those with relapsing-remitting MS.
Genentech noted that detailed data from the study 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 the year.
“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 patients [based on US PharMetrics commercial claims] continuing with treatment through 1 year,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Roche. “We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in healthcare systems.”
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