FDA Accepts sBLA for Shorter Infusion Time with Ocrelizumab

Genentech is seeking FDA approval for a 2-hour ocrelizumab (Ocrevus) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS), according to a press release.

The FDA accepted the company’s supplemental Biologics License Application (sBLA); if approved, the short infusion time would reduce infusion time to 2 hours from the current 3.5 hours for patients.

Ocrelizumab is the first therapy approved for both relapsing MS (including clinically isolated syndrome, RRMS, and active, or relapsing, SPMS) and primary progressive MS (PPMS), with dosing every 6 months.

The sBLA is based on data from the ENSEMBLE PLUS study, which showed comparable frequency and severity of infusion-related reactions (IRR) for a 2-hour ocrelizumab infusion time versus the currently-approved 3.5 hour time in patients with relapsing-remitting MS (RRMS).

In the study, the first dose was administered per the approved dosing schedule (two 300 mg intravenous [IV] infusions separated by 2 weeks) and the second or later doses (600 mg IV infusion) were administered over a shorter, 2-hour time.

Overall, the primary endpoint of the 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 due to an IRR and no new safety signals were detected, according to the study.

“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 continuing treatment through 1 year,” Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development, said in a press release. “We hope a shorter infusion time will further improve the experience for people living with MS while also increasing capacity in health care systems.”

References:

1. FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time. News Release; April 19, 2020. Accessed 20, 2020. https://www.gene.com/media/press-releases/14846/2020-04-19/fda-and-ema-accept-applications-for-gene.