Shots:

• The US FDA has accepted the sBLA and EMA has validated the application for a 2hrs. Ocrevus (ocrelizumab) infusion time- administered twice yearly for RMS and PPMS
• The sBLA is based on ENSEMBLE PLUS study- which demonstrated comparable frequency and severity of IRRs for a 2hrs. OCREVUS infusion time vs the currently approved 3.5hrs in patients with RRMS. The initial dose is given as two 300 mg infusions given 2wks. apart and a subsequent dose single 600mg infusions were administered over a shorter- 2hrs. time
• The FDA and the EC are anticipated to make decisions on the applications by H2’20. 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

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Ref: Roche | Image: Roche