Genentech, a member of the Roche Group (RHHBY), on Wednesday, announced data from the Phase III OCARINA II study (S31.006) of Ocrevus (ocrelizumab), an investigational twice-yearly, 10-minute subcutaneous or SC injection.
The study findings showed near-complete suppression of clinical relapses and brain lesions in individuals with relapsing or primary progressive multiple sclerosis (RMS or PPMS), highlighting the possible advantages of this investigational formulation. Ocrevus SC administration resulted in prompt and sustained depletion of B-cells in the blood.
Further data analysis confirmed that the safety profile of Ocrevus SC injection remained consistent with the well-established safety profile of Ocrevus IV infusion. There were no reports of any new safety signals for Ocrevus SC.
Data from the Phase III OCARINA II trial were submitted to health authorities around the world following the first presentation of these results during ECTRIMS-ACTRIMS 2023. Both the European Medicines Agency or EMA and the U.S. Food and Drug Administration or FDA have accepted Genentech's submissions, with a target decision date of mid-2024 for the EMA and September 2024 for the FDA.
The company further noted that the data will be presented as an oral presentation at the 76th American Academy of Neurology (AAN) Annual Meeting taking place April 13-18 in Denver and has been recognized as an abstract of distinction by the AAN scientific committee.
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