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Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis
OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion Provides an
About this update from Halozyme Therapeutics, Inc.
[{"type":"text","content":"OCREVUS® subcutaneous (SC) injection offers a new 10-minute administration with comparable efficacy and safety to intravenous (IV) infusion\nProvides an additional treatment option without the need for IV facilities, expanding accessibility for patients\nSAN DIEGO, June 25, 2024 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (\"Halozyme\") today announced that Roche received European Commission (EC) marketing authorization of OCREVUS® (ocrelizumab) SC co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).\nOCREVUS® 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.\n\"With OCREVUS SC, multiple sclerosis patients in the EU can now have their medicine administered in just 10 minutes, twice per year, and without the need for an IV facility,\" said Dr. Helen Torley, president and chief executive officer of Halozyme. \"This creates enhanced flexibility for both patients and providers and represents another example of how Halozyme's breakthrough technologies help to create improved treatment options.\"\nThe 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.\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 reducing treatment burden for patients. Having touched more than 800,000 patient lives in post-marketing use in seven commercialized products across more than 100 global markets, Halozyme has licensed its ENHANZE® techn...