FDA approves two-hour infusion treatment for relapsing and primary progressive MS
Roche announced that the U.S. Food and Drug Administration (FDA) 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).
The approval was based on data from the randomized, double-blind ENSEMBLE PLUS study. The 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.
