EU Approves Subcutaneous Version of Roche’s Ocrevus for Multiple Sclerosis

The European Commission has granted approval to Roche for a subcutaneous (SC) formulation of Ocrevus (ocrelizumab) for the treatment of both relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new SC version maintains the existing dosing schedule of the intravenous (IV) formulation, which is administered twice a year. Roche announced that this newly approved SC formulation is designed to be administered by healthcare providers, either in clinical settings or other healthcare environments.

Levi Garraway, Roche's chief medical officer, highlighted the convenience of the new SC formulation, noting that it allows patients in the European Union to receive their medication in just 10 minutes twice annually, eliminating the need for IV facilities. This advancement makes it easier for a broader range of patients to access their treatment while also saving valuable time for healthcare providers.

The approval by the European Commission is supported by data from the Phase III OCARINA II study. The study demonstrated that the SC formulation of Ocrevus produced non-inferior blood levels compared to the IV formulation. Additionally, the SC version exhibited a comparable safety and efficacy profile. The study also revealed that over 92% of participants were either satisfied or very satisfied with the SC formulation of the medication.

The SC version of Ocrevus employs Halozyme's Enhanze drug delivery technology and is also under review by the FDA, with a decision expected in September. A poll conducted by Firstword among US neurologists last year indicated a significant interest in the SC formulation. Nearly one-third of respondents expressed a preference for using the SC version exclusively if it received approval. Furthermore, half of the neurologists surveyed believed that the SC formulation of Ocrevus would offer a substantial competitive edge over other anti-CD20 therapies, such as Novartis’ Kesimpta (ofatumumab) and TG Therapeutics’ Briumvi (ublituximab).

Ocrevus continues to be Roche’s top-selling drug, achieving global sales of CHF 6.4 billion ($7.1 billion) last year, with the European Union contributing nearly CHF 1.1 billion ($1.2 billion) to this figure.