Halozyme Therapeutics, Inc. announced that Roche received European Commission marketing authorization of OCREVUS (ocrelizumab) SC co-formulated with ENHANZE, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuP H2 0, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion. The SC injection was designed to be administered by healthcare professionals, with the flexibility to be administered either in the clinic or in settings outside the clinic.

The EC approval is based on pivotal data from the Phase III OCARINA II trial, which showed non-inferior levels of OCREVUS in the blood, when administered subcutaneously, and a safety and efficacy profile comparable to the IV formulation in patients with RMS and PPMS. OCREVUS SC was well tolerated, and no new safety concerns were identified.