EC Approves Roche's Subcutaneous Ocrevus for Relapsing and Primary MS

Roche’s subcutaneous (SC) formulation of Ocrevus (ocrelizumab) has received marketing authorisation from the European Commission (EC) for the treatment of relapsing and primary multiple sclerosis (MS). This new SC version offers a ten-minute injection that maintains the same semi-annual schedule as the previously approved intravenous (IV) infusion, providing patients with an alternative that does not require IV facilities.

Multiple sclerosis, a neurological condition affecting approximately 2.9 million people worldwide, occurs when the immune system attacks the myelin sheath, a protective covering of the nerves. This disruption leads to communication issues between the brain and the body, causing a range of symptoms including weakness, fatigue, and vision problems. There are two main types of MS: relapsing-remitting MS, which accounts for about 85% of cases and is marked by episodes of new or worsening symptoms followed by recovery periods, and primary progressive MS, which affects around 15% of patients and is characterised by steadily worsening symptoms.

Ocrevus, developed by Roche, is a humanised monoclonal antibody designed to target specific immune cells believed to significantly contribute to myelin and axonal damage, potentially leading to disability in MS patients. The recent approval by the EC was based on positive results from the late-stage OCARINA II trial. This trial demonstrated that the SC administration of Ocrevus resulted in non-inferior levels of the drug in the blood compared to the IV formulation, with a comparable safety and efficacy profile in patients with both relapsing and primary MS.

In addition to the clinical data, patient satisfaction was also a key consideration in the approval. Over 92% of the patients surveyed during the OCARINA II study reported being satisfied or very satisfied with the subcutaneous administration of Ocrevus. This level of satisfaction highlights the convenience and potential benefits of the SC formulation for individuals living with MS.

Levi Garraway, Roche’s chief medical officer and head of global product development, highlighted the significance of this development for MS patients in the European Union. He pointed out that the SC formulation allows for medication administration in just ten minutes twice a year without the need for an IV facility. This advancement not only makes treatment more accessible for a broader range of patients but also saves valuable time for healthcare providers.

Roche’s recent approval of Ocrevus SC comes on the heels of a strategic partnership with Ascidian Therapeutics to develop RNA exon editing therapies for neurological diseases, a deal valued at over $1.8 billion. Additionally, Roche has entered into a strategic licence agreement with ALZpath for the use of its pTau217 antibody. This agreement aims to develop and commercialise a diagnostic blood test for Alzheimer’s disease, further expanding Roche’s portfolio in neurological diagnostics and treatment.

In summary, the EC's approval of Roche's SC formulation of Ocrevus marks a significant step forward in the treatment of multiple sclerosis. By offering a more convenient administration method without compromising efficacy or safety, this new option has the potential to improve the quality of life for many MS patients and streamline healthcare delivery in the EU.