FDA Approves Ocrevus Zunovo as First Subcutaneous Option for Multiple Sclerosis
核心洞察
The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for relapsing and primary progressive multiple sclerosis (搜索).
Ocrevus Zunovo offers a twice-yearly, 10-minute injection, providing an alternative to intravenous infusions.
The approval is supported by Phase III OCARINA II trial data, demonstrating comparable efficacy and safety to intravenous Ocrevus.
The U.S. Food and Drug Administration (FDA) has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of both relapsing multiple sclerosis (搜索) (RMS) and primary progressive multiple sclerosis (搜索) (PPMS), Roche announced. This approval marks a significant advancement in MS treatment, offering the first and only twice-a-year, approximately 10-minute subcutaneous (SC) injection administered by healthcare professionals. The new formulation provides an alternative for patients, potentially expanding treatment options to centers with limited IV infrastructure.
Clinical Efficacy and Safety
The FDA's decision is backed by data from the Phase III OCARINA II trial (NCT05232825), a global, multicenter, randomized study involving 236 patients with RMS or PPMS. The trial compared the pharmacokinetics, safety, and efficacy of subcutaneous Ocrevus Zunovo to intravenous (IV) Ocrevus. Results indicated that SC injection was non-inferior to IV infusion based on ocrelizumab levels in the blood. The study also demonstrated consistent control of clinical (relapses) and radiological (MRI lesions) disease activity. Specifically, Ocrevus Zunovo showed a 97% suppression of relapse activity and MRI lesions through 48 weeks, aligning with the efficacy of IV Ocrevus.
Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of Global Product Development, stated, "OCREVUS ZUNOVO gives patients and providers another option for receiving OCREVUS, building on a decade of robust safety and efficacy data for OCREVUS in multiple sclerosis (搜索). This approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs."
Safety Profile and Tolerability
The safety profile of Ocrevus Zunovo was consistent with the established safety profile of IV Ocrevus, with the exception of injection site reactions. Injection reactions were more frequently reported with the first injection, with 49% of trial participants experiencing a reaction. However, all injection reactions were mild or moderate, and none led to treatment withdrawal.
Mechanism of Action
Ocrevus Zunovo combines ocrelizumab with Halozyme Therapeutics’ Enhanze drug delivery technology. Ocrelizumab is a humanized monoclonal antibody designed to target CD20 (搜索)-positive B cells, which are believed to contribute to myelin and axonal damage in MS. The Enhanze technology utilizes recombinant human hyaluronidase PH20 (rHuPH20) to temporarily degrade hyaluronan in the subcutaneous space, increasing tissue permeability and enabling rapid dispersion and absorption of ocrelizumab into the bloodstream.
Impact on MS Treatment Landscape
Multiple sclerosis (搜索) is a chronic disease affecting over 2.9 million people worldwide. It is characterized by the immune system attacking the myelin sheath around nerve cells in the central nervous system, leading to a range of symptoms and potential disability. Ocrevus and Ocrevus Zunovo are the only therapies approved for both RMS (including relapsing-remitting MS and active, or relapsing secondary progressive MS, as well as clinically isolated syndrome in the U.S.) and PPMS. The availability of a subcutaneous formulation offers increased convenience and accessibility, potentially improving treatment adherence and outcomes for patients with MS.
Natalie Blake, Executive Director of the MS Foundation, emphasized the importance of treatment options, stating, "It’s crucial to acknowledge each experience with MS is as unique as the individual navigating it, so providing choices to address each person’s needs is essential. 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."