FDA Approves Genentech's Ocrevus Zunovo as First Twice-Yearly Subcutaneous MS Treatment
核心洞察
The FDA has approved Ocrevus Zunovo, a subcutaneous injection, for relapsing and primary progressive multiple sclerosis (搜索).
Ocrevus Zunovo is the first and only twice-a-year, 10-minute subcutaneous treatment option for both forms of MS.
Approval was based on the Phase III OCARINA II trial, demonstrating similar efficacy and safety to the IV formulation of Ocrevus.
Genentech, a member of the Roche Group, has received FDA approval for Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (搜索) (RMS) and primary progressive multiple sclerosis (搜索) (PPMS). This marks the first and only twice-a-year, approximately 10-minute subcutaneous (SC) injection approved for both RMS and PPMS, offering a new treatment option for individuals living with MS. The approval is based on data from the Phase III OCARINA II trial, which demonstrated comparable efficacy and safety to the intravenous (IV) formulation of Ocrevus. This subcutaneous option provides increased flexibility for healthcare providers and patients, particularly those in settings with limited IV infrastructure. Multiple sclerosis (搜索) is a chronic disease affecting more than 2.9 million people worldwide, and Ocrevus Zunovo provides a new avenue for managing this condition.
Ocrevus Zunovo: A New Subcutaneous Option
Ocrevus Zunovo combines ocrelizumab with Halozyme Therapeutics’ Enhanze drug delivery technology. Ocrelizumab is a humanized monoclonal antibody that targets 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, enhancing tissue permeability and allowing for rapid dispersion and absorption of ocrelizumab into the bloodstream. This subcutaneous formulation offers a shorter administration time and potentially greater convenience compared to the traditional IV infusion.
Clinical Trial Data and Efficacy
The FDA approval was primarily supported by data from the Phase III OCARINA II trial (NCT05232825), a global, multicenter, randomized study involving 236 patients with RMS or PPMS. The trial evaluated the pharmacokinetics, safety, and clinical and radiological efficacy of subcutaneous Ocrevus compared to intravenous Ocrevus. Results indicated that the subcutaneous injection was non-inferior to the IV infusion in terms of 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, consistent with the IV formulation. Furthermore, over 92% of trial participants reported being satisfied or very satisfied with the subcutaneous administration.
Safety Profile and Adverse Events
The safety profile of Ocrevus Zunovo in the OCARINA II trial was consistent with the well-established safety profile of Ocrevus IV, with the exception of injection reactions. Injection reactions were the most common adverse events, with 49% of participants experiencing them after the first injection. However, all injection reactions were reported as mild or moderate, and none led to treatment withdrawal. Other potential side effects include respiratory tract infections and skin infections.
Implications for MS Treatment
The approval of Ocrevus Zunovo offers several advantages for patients with MS. The shorter, twice-yearly subcutaneous injection provides a more convenient administration route compared to the IV infusion, potentially improving patient adherence and quality of life. Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, stated that this approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis (搜索), based on their individual treatment needs. Natalie Blake, Executive Director of the MS Foundation, emphasized the importance of providing choices to address each person’s needs, noting that the new delivery method offers an additional option for those who need flexibility in the route of administration or treatment time. With over 350,000 people treated globally with Ocrevus IV, the subcutaneous formulation has the potential to expand treatment options, especially in centers without extensive IV infrastructure.