Roche announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs), according to a press release from Roche.
The approval was based on data from the randomized, double-blind ENSEMBLE PLUS study.
The ENSEMBLE PLUS study showed similar frequency and severity of IRs for a two-hour OCREVUS infusion time versus the previously approved 3.5-hour time in patients with relapsing-remitting MS (RRMS). The first dose was administered per the approved dosing schedule (two 300 mg intravenous [IV] 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 IRs following the first randomized 600 mg infusion (frequency/severity assessed during and 24-hours post infusion). The frequency of IRs was comparable between those who received the two-hour infusion (24.6 percent) and those who received the 3.5-hour infusion (23.1 percent). The majority of IRs were mild or moderate, and more than 98 percent resolved in both groups without complication. No IRs were life-threatening, serious or fatal. No patients discontinued the study due to an IR and no new safety signals were detected.
