04:41 AM EDT, 06/25/2024 (MT Newswires) -- Halozyme Therapeutics ( HALO ) said Tuesday that Roche received European Commission marketing authorization of OCREVUS SC co-formulated with ENHANZE, Halozyme's proprietary recombinant human hyaluronidase enzyme, for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis.
OCREVUS SC is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion, the company said.
The approval is based on 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.