FDA Okays Subcutaneous Ocrelizumab for MS

The US Food and Drug Administration (FDA) has approved a subcutaneous formulation of the anti-CD20 antibody ocrelizumab (Ocrevus Zunovo, Genentech) for treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). 

The subcutaneous (SC) injection can be administered by a healthcare professional in approximately 10 minutes and is the first and only twice-a-year SC injection approved for both RMS and PPMS, according to a company news release.

The FDA approval is based on pivotal data from the phase 3 OCARINA II trial, which showed no clinically significant difference in blood levels of ocrelizumab when administered subcutaneously and an efficacy profile consistent to the intravenous (IV) formulation, as previously reported by Medscape Medical News. 

“The trial met its primary and secondary endpoints, demonstrating SC injection was non-inferior to IV infusion based on [ocrelizumab] levels in the blood, and consistent control of clinical (relapses) and radiological (MRI lesions) disease activity,” the company said in the release. 

The safety profile of SC ocrelizumab was consistent with the safety profile of IV ocrelizumab, with the exception of injection site reactions, which were the most common adverse event.

Injection reactions were more often reported with the first injection, with 49% of trial participants experiencing an injection reaction after the first injection. All injection reactions were either mild or moderate, and none led to treatment withdrawal.

Ocrevus Zunovo “may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs,” Levi Garraway, MD, PhD, Genentech’s chief medical officer, said in the release. 

“We are pleased that with a new method of delivery, there is now an additional option for those who need flexibility in the route of administration or treatment time,” Natalie Blake, executive director of the MS Foundation, said in the release. 

The SC formulation of ocrelizumab was approved by the European Commission in June.

Complete prescribing information is available online.