Roche Holding AG (RHHBY) Tuesday said that the European Commission has granted marketing authorisation for Ocrevus subcutaneous injection for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus intravenous infusion is already approved for the disease.
Ocrevus subcutaneous is co-formulated with Halozyme's ENHANZE drug delivery technology with the proprietary enzyme rHuPH20.
"Now, people in the EU with multiple sclerosis can have their medicine administered in just 10 minutes twice per year without needing an IV facility," said Levi Garraway, Roche's Chief Medical Officer and Head of Global Product Development.
The approval is based on 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.
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