Roche has announced positive results from a late-stage study of Ocrevus (ocrelizumab) as a twice-yearly subcutaneous injection in patients with relapsing forms of multiple sclerosis (MS) or primary progressive MS.
Over 2.8 million people worldwide are affected by MS, a disabling and unpredictable neurological disease in which the immune system attacks the protective myelin sheath that covers the nerves, disrupting 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 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 therapy is already approved in major markets to treat patients with relapsing MS or primary progressive MS in the form of a twice-yearly intravenous infusion (IV).
Roche outlined that the investigational subcutaneous formulation of Ocrevus has the potential to “further improve the treatment experience” and expand usage to MS centres without IV infrastructure or with IV capacity limitations.
The phase 3 OCARINA 2 study has been evaluating the subcutaneous formulation compared with the IV in 236 patients with relapsing or primary progressive MS.
The Ocrevus subcutaneous injection was shown to be non-inferior to the IV, as measured by pharmacokinetics (levels in the blood) over 12 weeks.
The subcutaneous injection was also comparable in controlling MRI lesion activity in the brain over 12 weeks, and its safety profile was consistent with Ocrevus IV.
Levi Garraway, Roche’s chief medical officer and head of global product development, said: “These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources.
“This new subcutaneous injection will allow Ocrevus to be administered in ten minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’