California-based biopharmaceutical company Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced on Friday that Roche (SWX:ROG), a Switzerland-based healthcare company, has received approval for OCREVUS ZUNOVO (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE drug delivery technology from US Food and Drug Administration (FDA).

The combination is intended for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) as a twice-a-year, approximately 10-minute subcutaneous (SC) injection to be administered by a healthcare practitioner.

The FDA 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 intravenous (IV) formulation in people with RMS and PPMS.

Dr Helen Torley, Halozyme president and CEO said that now that the subcutaneous formulation of OCREVUS, OCREVUS ZUNOVO, which contains our ENHANZE drug delivery technology, is now approved in the US for patients with these two forms of multiple sclerosis, there will be greater treatment flexibility and optionality for patients with multiple sclerosis and their healthcare providers.