ridvan_celik/iStock via Getty Images Halozyme Therapeutics ( NASDAQ: HALO ) Tuesday said that Roche received European Commission marketing authorization for Ocrevus subcutaneous co-formulated with Enhanze, Halozyme's ( HALO ) proprietary recombinant human hyaluronidase enzyme, for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis. Ocrevus subcutaneous is a 10-minute injection that maintains the same twice-yearly schedule as the approved IV infusion. The 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, Halozyme Therapeutics ( HALO ) said.
"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. The 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.
Source: Press Release More on Halozyme Therapeutics Halozyme Therapeutics: The Story Brightens Halozyme Therapeutics, Inc. (HALO) Q1 2024 Earnings Call Transcript Halozyme Therapeutics, Inc. 2024 Q1 - Results - Earnings Call Presentation Bristol Myers Opdivo injectable accepted for.