Genentech, a member of the Roche Group, announced this week that its 10-minute subcutaneous injection formulation of multiple sclerosis (MS) blockbuster Ocrevus performed just as well as the original IV formulation of the treatment.
Data from the OCARINA II phase 3 study demonstrated that the Ocrevus injection was just as effective as the traditional method, as evidenced by Ocrevus levels in patients' blood over a span of 12 weeks. Data also found that the injection mirrored its IV formulation safety record.
Importantly, the subcutaneous injection demonstrated rapid and sustained B cell depletion, closely resembling the results achieved with the IV infusion. It also offered near-complete suppression of MRI lesion activity over the course of 24 weeks, an indicator of disease progression.
The injection formulation combines the anti-CD20 monoclonal antibody with Halozyme Therapeutics' Enhanze drug delivery technology. Enhanze works by temporarily enhancing the permeability of subcutaneous tissue, allowing for improved absorption of the drug.
The new formulation option is designed to be delivered twice-yearly by a health care provider, without the need for IV infrastructure — which means it has the potential to expand the usage of Ocrevus in treatment centers without IV infrastructure or those with IV capacity limitations.
Ocrevus was first approved by the FDA in 2017 for use in patients with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis. The drug generated more than $1 billion in sales the year after its launch.
Multiple sclerosis is a chronic condition affecting more than 2.8 million people worldwide. It results from the immune system targeting the insulation around nerve cells, leading to inflammation and damage. Genentech is also currently assessing how its Bruton tyrosine kinase inhibitor MS drug, fenebrutinib, compares to Ocrevus.