FDA Approves Roche’s Injectable Ocrevus Zunovo for MS

Roche has secured approval from the US Food and Drug Administration (FDA) for its new injectable monoclonal antibody, Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), which will treat both relapsing and primary progressive multiple sclerosis (MS). This new subcutaneous (SC) formulation, which integrates Ocrevus (ocrelizumab) with Halozyme Therapeutics’ Enhanze drug delivery technology, allows for injections over approximately ten minutes. Importantly, it maintains the same twice-yearly dosing schedule as the previously approved intravenous (IV) infusion.

Multiple sclerosis is a neurological condition affecting over 2.9 million people worldwide. In this disease, the immune system attacks the myelin sheath protecting nerve fibers, which leads to disrupted communication between the brain and other parts of the body. There are two primary types of MS: relapsing-remitting MS, which accounts for about 85% of cases, and primary progressive MS, which affects the remaining 15%. The former is characterized by episodes of new or worsening symptoms followed by recovery periods, while the latter sees symptoms steadily worsen.

Ocrevus is a disease-modifying therapy designed by Roche to target specific immune cells responsible for myelin and axonal damage, potentially leading to disability in MS patients. The FDA’s recent approval was influenced by positive results from the OCARINA II trial, a late-stage study showing no clinically significant difference in blood levels of Ocrevus when administered subcutaneously compared to intravenously. The trial also confirmed that the safety and efficacy profiles of the SC and IV formulations were comparable in patients with relapsing and primary progressive MS.

Moreover, the study revealed that over 92% of surveyed patients expressed satisfaction with the SC administration method. Levi Garraway, Roche’s chief medical officer and head of global product development, emphasized that Ocrevus Zunovo offers patients and healthcare providers an alternative method of administration, based on a decade of robust safety and efficacy data for Ocrevus in MS. This new approval could provide greater flexibility for healthcare providers and patients, considering individual treatment needs.

This FDA authorisation follows closely on the heels of similar approvals by the Medicines and Healthcare products Agency (MHRA) in the UK and the European Commission, both of which also sanctioned the SC formulation for treating MS. The recent milestones further extend the availability of Ocrevus Zunovo, potentially improving life quality for many MS sufferers around the globe.