US FDA nod for Ocrevus (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive MS
Approval based on data from the randomised, double-blind ENSEMBLE PLUS study, showing consistent safety to the conventional Ocrevus dosing regimen
Genentech, a member of the Roche Group announced that the US 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). The approval was based on data from the randomised, double-blind ENSEMBLE PLUS study.
The ENSEMBLE PLUS study showed similar frequency and severity of IRs for a two-hour Ocrevus infusion time vs. 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 randomised 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 per cent) and those who received the 3.5-hour infusion (23.1 per cent). The majority of IRs were mild or moderate, and more than 98 per cent 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.
The European Medicines Agency (EMA) approved the two-hour infusion time in May of 2020 based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for relapsing multiple sclerosis (RMS) (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the US) and primary progressive MS (PPMS). Ocrevus is approved in 94 countries across North America, South America, the Middle East, Europe, as well as in Australia.
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