FDA Approves Shorter 2-Hour Infusion for Roche’s Ocrevus (ocrelizumab) in Relapsing and Primary Progressive Multiple Sclerosis

Compiled by Keke

On December 14, Genentech, a member of the Roche Group, announced that the U.S. FDA had approved a shorter two-hour infusion regimen of Ocrevus® (ocrelizumab) for twice-yearly administration in patients with relapsing or primary progressive multiple sclerosis (MS) who have never experienced any serious infusion reactions (IRs). Previously, in May 2020, the European Medicines Agency (EMA) had approved the two-hour infusion time for Ocrevus, based on the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).

This approval is based on data from the randomized, double-blind clinical study ENSEMBLE PLUS. Genentech stated that the ENSEMBLE PLUS study demonstrated that the efficacy of Ocrevus administered via a 2-hour infusion in patients with relapsing-remitting multiple sclerosis (RRMS) was comparable to that of Ocrevus administered via the previously approved 3.5-hour infusion. The first dose was administered according to the approved 3.5-hour dosing regimen (two 300 mg intravenous infusions separated by two weeks), while the second or subsequent doses (600 mg intravenous infusion) were administered over a shorter infusion time of 2 hours.

The primary endpoint of this study was the proportion of patients experiencing infusion-related reactions (IRs) after the first randomized 600 mg infusion (with frequency/severity of IRs assessed during and within 24 hours after infusion). The incidence of IRs was comparable between patients receiving a 2-hour infusion (24.6%) and those receiving a 3.5-hour infusion (23.1%). Most IRs were mild or moderate, accounting for over 98% in both groups, with no complications. No severe or fatal IRs occurred. No patients discontinued the study due to IRs, and no new safety signals were identified.

Patients with various types of multiple sclerosis (MS) experience neuroinflammation and permanent loss of neuronal cells in the brain, even when their clinical symptoms are subtle or appear stable. Therefore, a key treatment objective is to reduce disease activity as early as possible to slow the rate of disability progression.

Ocrelizumab is a humanized monoclonal antibody targeting CD20-positive B cells, a specific type of immune cell considered to be a key factor in the damage to myelin (the insulating and supportive layer of nerve cells) and axons (nerve fibers). Such neuronal damage can lead to disability in patients with multiple sclerosis (MS). It is reported that prior to the U.S. FDA approval of Ocrevus, there were no approved treatments for primary progressive multiple sclerosis (PPMS). According to preclinical studies, Ocrevus binds to the CD20 cell surface protein expressed on certain B cells, but not on stem cells or plasma cells, suggesting that important functions of the immune system may be preserved.

Reference: FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis