Roche has recently announced the EMA (European Medicines Agency) approval for a new, shorter 2-hour infusion time of OCREVUS® (ocrelizumab). This can be dosed twice a year for the relapsing or primary progressive MS (multiple sclerosis). This approval is based on the positive opinion of CHMP (Committee for Medicinal Products) of the EMA.
According to Levi Garraway, M.D., Ph.D., Roche’s CEO & head of Global Product Development, the recent approval of a 2-hour infusion time in Europe will increase the capacity of healthcare systems as well as enhance the treatment experience among patients. The shorter infusion period will aid both patients & healthcare providers and lead to the slowdown of disease progression in MS. A total number of more than 160,000 patients are treated with OCREVUS across the globe.
The approval is based on a double-blind, randomized ENSEMBLE PLUS study’s data. The data showed comparable severity and frequency of IRRs (infusion-related reactions) for the 2-hour OCREVUS infusion time v/s conventional 3.5-hour among patients with RRMS (relapsing-remitting MS). The 1st dose was administered to patients as per the approved schedule, i.e. two 300mg IV infusions separated by 2 weeks. The 2nd or later doses of 600mg IV infusion were administered in a shorter, 2-hour period.
The IRRs frequency was comparable between those patients who obtained the 2-hour infusion (24.6%) as well as 3.5-hour infusion (23.1%). Most IRRs were moderate or mild, with a 98% resolution rate in both the groups without complications. IRRs did not appear to be life-threatening, fatal or serious. Additionally, there were no single patients who discontinued the study and no safety signals being detected.
The U.S. FDA previously accepted a supplementary BLA (Biologics License Application) for a 2-hour infusion time of OCREVUS, which is expected to be decided by 14th December 2020. OCREVUS has been approved for use in 90 countries across Eastern Europe, the Middle East, South America, North America as well as the EU, Switzerland, and Australia.