Roche ’s OCREVUS subcutaneous injection receives EU CHMP positive opinion for relapsing and primary progressive multiple sclerosis

If approved, OCREVUS subcutaneous (SC) would be the first and only twice-a-year, 10-minute injection for relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in the EUOCREVUS SC will be a new, faster way of administering OCREVUS with a comparable efficacy and safety profile tothe well-established intravenous (IV) infusionOCREVUS SC has the potential to expand treatment optionsto centres without IV infrastructure or with IV constraintsBasel, 29 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency ’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of OCREVUS® (ocrelizumab) subcutaneous (SC) for its multiple sclerosis (MS) indications. OCREVUS SC maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, with a 10-minute injection. A final decision on its approval from the European Commission is expected mid-2024.“More than 300,000 people with MS have been treated globally with twice-a-year OCREVUS IV infusions to date. However, access to IV facilities may be challenging for some patients, and, conversely, some MS centres have limited IV capacity,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The CHMP’s recommendation brings us a step closer to offering the 10-minute OCREVUS SC injection in the EU, expanding access to even more people with MS who could benefit f...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news