Roche Group (SWX: ROG; OTCMKTS: RHHBY) , a Swiss pharmaceutical giant, has announced that the US Food and Drug Administration (FDA) has granted approval for Ocrevus Zunovo (ocrelizumab, hyaluronidase), marking a significant advancement in the treatment of multiple sclerosis (MS). This new formulation is the first and only twice-per-year treatment option for MS, indicated for both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
Ocrevus Zunovo integrates the CD20-targeted antibody ocrelizumab with Halozyme Therapeutics’ Enhanze drug delivery technology, an innovative enzyme that facilitates the subcutaneous administration of drugs and fluids. The treatment process with Ocrevus Zunovo is expedited, taking only 55 minutes to administer, following premedications that are required at least 30 minutes before each dose. This approval is supported by a solid foundation of safety and efficacy data from a decade of intravenous Ocrevus use, as well as the Phase III OCARINA II trial. The trial demonstrated no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously, maintaining a safety and efficacy profile consistent with the intravenous formulation for patients with RMS and PPMS. – Flcube.com
