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Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis
OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints SAN DIEGO, Sept. 13, 2024
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"OCREVUS ZUNOVO™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints\nSAN DIEGO, Sept. 13, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™ (ocrelizumab and hyaluronidase-ocsq) with Halozyme's ENHANZE® drug delivery technology 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.\n\"We are pleased that the subcutaneous formulation of OCREVUS, OCREVUS ZUNOVO, which contains our ENHANZE drug delivery technology, is now approved in the U.S. for patients with these two forms of multiple sclerosis,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"OCREVUS ZUNOVO offers greater treatment flexibility and optionality for patients with multiple sclerosis and their healthcare providers.\"\nThe 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. The most common adverse events with OCREVUS ZUNOVO were injection reactions, all of which were either mild or moderate, and none of which led to treatment withdrawal. Out of the exploratory outcomes measured, OCREVUS ZUNOVO was consistent with IV, demonstrating suppression of relapse activity (97%) and MRI lesions (97%) through 48 weeks. Additionally, there were patient-reported outcomes measured during the study, that showed more than 92% of trial participants reported being satisfied or very satisfied with the SC administration of OCREVUS ZUNOVO.\nAbout Halozyme\nHalozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of improving the patient experience with rapid subcutaneous del...