Roche’s injectable monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) has been approved by the US Food and Drug Administration (FDA) to treat both relapsing and primary progressive multiple sclerosis (MS).
The subcutaneous (SC) formulation, which combines Ocrevus (ocrelizumab) with Halozyme Therapeutics’ Enhanze drug delivery technology, can be injected over approximately ten minutes while maintaining the same twice-yearly dosing schedule as the previously approved intravenous (IV) infusion.
Affecting more than 2.9 million people globally, MS is a neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves and disrupts communication between the brain and the rest of the body.
Relapsing-remitting MS accounts for approximately 85% of MS cases and is characterised by episodes of new or worsening signs or symptoms followed by periods of recovery, while primary progressive MS affects about 15% of patients and is marked by steadily worsening symptoms.
Roche’s Ocrevus is a disease-modifying therapy designed to target a type of immune cell thought to be a key contributor to myelin and axonal damage, which can lead to disability in MS patients.
The FDA’s latest decision on the therapy was supported by positive results from the late-stage OCARINA II trial, which demonstrated no clinically significant difference in the levels of Ocrevus in the blood when administered subcutaneously, as well as a safety and efficacy profile comparable to the IV formulation in patients with relapsing and primary MS.
Additionally, over 92% of patients who were surveyed as part of the study reported being satisfied or very satisfied with the SC administration.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Ocrevus Zunovo gives patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data for Ocrevus in MS.
“This approval may offer greater flexibility for healthcare providers and people living with MS, based on their individual treatment needs.”
The authorisation comes just three months after the SC formulation was approved by the Medicines and Healthcare products Agency for the same indication. SC Ocrevus has also been granted marketing authorisation by the European Commission.