Roche’s subcutaneous (SC) formulation of its Ocrevus (ocrelizumab) has been granted marketing authorisation by the European Commission (EC) to treat relapsing and primary multiple sclerosis (MS).
Ocrevus SC is a ten-minute injection that maintains the same twice-yearly schedule as the previously approved intravenous (IV) infusion, providing an additional treatment option for patients without the need for IV facilities.
Affecting approximately 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, causing symptoms such as weakness, fatigue and vision problems.
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 humanised monoclonal antibody 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 people with MS.
The EC’s latest decision on the therapy is supported by positive results from the late-stage OCARINA II trial, which demonstrated non-inferior 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 of Ocrevus.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “Now, people in the EU with MS can have their medicine administered in just ten minutes twice per year without needing an IV facility. This makes it easier for more [patients] to access their treatment, while also saving time for providers.”
The approval comes just one week after Roche partnered with Ascidian Therapeutics to develop RNA exon editing therapies for neurological diseases, with the deal worth over $1.8bn.
The company also recently entered into a strategic licence agreement for the use of ALZpath’s pTau217 antibody to develop and commercialise a diagnostic blood test for Alzheimer’s disease.