Roche’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time Receives EMA’s Approval for Relapsing or Primary Progressive Multiple Sclerosis

Shots:

• The approval is based on ENSEMBLE PLUS study, which demonstrated comparable frequency and severity of IRRs for 2hrs. OCREVUS infusion time (dosed twice yearly) vs conventional 3.5hrs in patients with RRMS. The initial dose is given as two 300mg infusions given 2wks. apart and a subsequent dose single 600mg infusions were administered over a shorter, 2hrs. time
• Results: frequency of IRRs post 600mg infusion (24.6% vs 23.1%), majority of IRRs were mild or moderate, and >98% resolved in both groups without complication. The approval follows CHMP’s positive opinion shorter two-hrs. dosing regimen
• Ocrevus is a mAb targeting CD20-positive B cells and is the first and only therapy approved for both RMS (including RRMS and active/ relapsing, SPMS, in addition to CIS in the US) and PPMS. The US FDA has accepted the sBLA for 2hrs. OCREVUS infusion time with the expected decision by Dec 14, 2020

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Related News: Roche Reports the FDA and EMA’s Acceptance of sBLA for Ocrevus Shorter 2-Hour Infusion Time