FDA Approves Subcutaneous Ocrelizumab (Ocrevus Zunovo) for Multiple Sclerosis
核心洞察
The FDA has approved subcutaneous ocrelizumab (Ocrevus Zunovo) for relapsing and primary progressive multiple sclerosis (搜索) (MS).
Ocrevus Zunovo offers a new twice-yearly, 10-minute injection option, providing greater flexibility for patients and healthcare providers.
The approval was based on the OCARINA II trial, demonstrating comparable efficacy and safety to intravenous ocrelizumab.
The FDA has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of both relapsing multiple sclerosis (搜索) (RMS) and primary progressive multiple sclerosis (搜索) (PPMS). This new formulation, administered subcutaneously, offers a convenient 10-minute injection twice a year, providing an alternative to the traditional intravenous (IV) infusion.
Clinical Efficacy and Safety
The approval is supported by data from the Phase III OCARINA II trial (NCT05232825), a global, randomized study that compared the pharmacokinetics of subcutaneous ocrelizumab with its intravenous counterpart. The study met its primary endpoint, demonstrating non-inferiority of the 920-mg subcutaneous dose to the 600-mg IV dose.
Data presented at MSMilan 2023 showed similar exposure levels of the drug over 12 weeks in both subcutaneous and IV groups. Specifically, the geometric mean ratio of area under the curve (AUC) for subcutaneous versus IV administration was 1.29 (90% CI, 1.23-1.35). Disease activity was well-controlled, with 99% of patients in both groups experiencing no relapses up to week 24.
Adverse Events
While the subcutaneous group reported a higher incidence of adverse events (73.7%) compared to the IV group (45.8%), serious adverse events were comparable (2.5% vs. 3.4%, respectively). The difference in adverse event rates was primarily driven by mild to moderate injection site reactions, such as erythema (29.7%), pain (14.4%), swelling (8.5%), and pruritus (6.8%), which were generally non-treatment limiting and resolved spontaneously.
Dosage and Administration
Patients receiving subcutaneous ocrelizumab will require premedication at least 30 minutes prior to each dose. Monitoring by healthcare providers is necessary for at least 60 minutes after the first injection and 15 minutes after subsequent injections. The optimal dosage of 920 mg was determined in the OCARINA I trial.
Impact on Patient Care
The approval of Ocrevus Zunovo offers a valuable alternative for patients seeking more flexible treatment options. Natalie Blake, executive director of the MS Foundation, emphasized the importance of providing choices to address individual needs, noting that the new delivery method offers flexibility in administration route and treatment time. Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech, stated that Ocrevus Zunovo builds on a decade of robust safety and efficacy data, potentially offering greater flexibility for healthcare providers and people living with multiple sclerosis (搜索).