Roche has received approval from the European Commission for OCREVUS® (ocrelizumab) subcutaneous (SC) formulation, expanding its use to treat both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new SC formulation allows for a quick 10-minute injection, maintaining the twice-yearly dosing schedule of the previously approved intravenous (IV) infusion. Globally, over 350,000 people have been treated with the IV form of OCREVUS for multiple sclerosis.

Dr. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development, emphasized the approval's significance, noting that OCREVUS SC provides greater convenience by eliminating the need for IV facilities. The approval is based on Phase III OCARINA II trial data, which demonstrated comparable efficacy and safety between the SC and IV formulations in RMS and PPMS patients. The SC formulation was well-tolerated, with high patient satisfaction reported during the study.

OCREVUS SC utilizes Halozyme Therapeutics’ ENHANZE® technology, which enhances delivery via subcutaneous injection. This innovation aims to improve treatment accessibility and flexibility for both patients and healthcare providers, enabling administration in clinical and non-clinical settings alike.

Multiple sclerosis affects over 2.9 million people worldwide, causing damage to nerve cell insulation and leading to a range of debilitating symptoms. OCREVUS, as the first anti-CD20 therapy approved for RMS and PPMS, continues to advance treatment options and research efforts in the field of multiple sclerosis.

 

Source: globenewswire.com

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