10-Minute Subcutaneous Injection Found Comparable to IV with Multiple Sclerosis Patients

Genentech today announced that the Phase III OCARINA II clinical trial evaluating Ocrevus® (ocrelizumab) as a twice-a-year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of Multiple Sclerosis (MS) or primary progressive MS (RMS or PPMS).

In this clinical trial, Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks.

Additionally, Ocrevus subcutaneous injection was comparable with Ocrevus IV in controlling brain magnetic resonance imaging lesion activity over 12 weeks.

“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,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, in a press release on July 13, 2023.

“This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’

Ocrevus is not a vaccine but is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to nerve cell insulation and support and nerve cell damage. 

The Ocrevus 10-minute injection is designed to be administered without the need for IV infrastructure. Hence, it can potentially expand the usage of Ocrevus in MS centers without IV infrastructure or those with IV capacity limitations.

It also retains the twice-yearly dosing regimen of Ocrevus IV that has shown high persistence and adherence since becoming a standard of care MS treatment. 

This provides an additional delivery option so that the administration of Ocrevus can be matched to the individual needs of patients and healthcare professionals.

The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics’ Enhanze® drug delivery technology.

Ocrevus remains the first and only therapy approved for RMS and PPMS, and more than 300,000 people have been treated globally.