MHRA approves Roche’s subcutaneous Ocrevus for relapsing and primary MS

Roche’s subcutaneous (SC) formulation of Ocrevus (ocrelizumab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for adults with relapsing and primary progressive multiple sclerosis (MS). This new method of administration offers a ten-minute injection that maintains the same biannual schedule as the previously approved intravenous (IV) infusion. It provides an additional option for patients, allowing them to spend less time in medical settings.

MS is a neurological condition affecting over 150,000 individuals in the UK. Symptoms include blurred vision, weakness in the limbs, tingling sensations, balance issues, memory difficulties, and fatigue. There are two primary types of MS: relapsing-remitting MS and primary progressive MS. Relapsing-remitting MS, which constitutes approximately 85% of cases, is characterized by episodes of new or worsening symptoms followed by recovery periods. Primary progressive MS affects about 15% of patients and involves steadily worsening symptoms.

Ocrevus is a disease-modifying therapy that targets specific immune cells believed to contribute significantly to myelin and axonal damage, potentially leading to disability in MS patients. Clinical trials provided the basis for the MHRA's recent approval, demonstrating that the SC formulation is as effective as the IV version. The results indicated that 97% of patients experienced no relapses and no new brain lesions over a 48-week period.

The National Health Service (NHS) announced that the SC formulation of Ocrevus would be available in the "coming weeks," positioning the NHS as one of the first healthcare systems globally to offer this new injection. Sir Stephen Powis, NHS national medical director, stated that Ocrevus has significantly advanced MS care in recent years by being the first drug capable of altering the disease's course. He expressed hope that the new, quicker injection option would further improve patients' quality of life and reduce hospital visits for treatment.

Beyond reducing treatment time for patients, the SC formulation of Ocrevus is expected to save clinicians' time and increase hospital capacity. Ceri Smith, head of policy at the MS Society, emphasized that this new administration method expands the choices available to MS patients, allowing more people to receive treatment conveniently.

By offering a quicker and equally effective alternative to the traditional IV infusion, the SC formulation of Ocrevus represents a significant step forward in the management of multiple sclerosis. The approval of this new administration method not only provides patients with greater flexibility but also optimizes healthcare resources, benefiting both patients and healthcare providers.