Roche's Ocrevus Bags Marketing Approval From European Commission

Roche, a leading pharmaceutical firm, declared that the European Commission has given marketing authorisation for Ocrevus (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Ocrevus SC is a 10-minute injection that keeps up with a similar two times yearly schedule as the previously approved intravenous (IV) infusion. In excess of 350,000 individuals with numerous sclerosis have been treated with Ocrevus IV universally.    

“Ocrevus transformed the way multiple sclerosis is treated as the first anti-CD20 therapy approved in this disease. 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, M.D., Ph.D., Roche’s chief medical officer and head of global product development. “This makes it easier for more people with multiple sclerosis to access their treatment, while also saving time for providers.”

The pivotal data from the phase III OCARINA II clinical trial, which demonstrated a safety and efficacy profile comparable to that of the IV formulation in patients with RMS and PPMS, and non-inferior blood levels of Ocrevus when administered subcutaneously, are the foundation of the approval. Ocrevus SC was endured and no new security concerns were recognized. Over 92% of patients who were reviewed as a part of the review detailed being fulfilled or extremely satisfied with the SC organization of Ocrevus.