FDA approves subcutaneous Ocrevus in the US

Ocrevus Zunovo is a twice yearly, under the skin treatment offered in clinic

“This is something than can be provided in clinics and doesn’t require people to go to an infusion center,” David Jones, Genentech’s Medical Director for MS, said in an interview. “This will expand access to individuals who may not be able to access Ocrevus now, especially for reasons like geography or rural setting, individuals that might have challenges with their healthcare provider.”

Ocrevus Zunovo can be injected in 10 minutes, compared to the two-plus hours needed for an infusion of the drug.

The OCARINA II study showed that 97% of patients on subcutaneous Ocrevus experienced no relapses for up to 48 weeks after injection. The subcutaneous treatment also suppressed brain lesions by 97%. Most patients had no T1 gadolinium-enhancing lesions or worsening T2 lesions, which are markers of active inflammation and burden of disease.

Ocrevus Zunovo requires more medicine, at 920 mg per dosing, versus 600 mg for an infusion. Ocrevus is designed to target CD20-positive B cells, which are responsible for inflammatory damage to nerve cells in MS.

The new formulation is already approved in the EU and UK.