FDA Approves Ocrevus ZUNOVO: First Subcutaneous Injection for Multiple Sclerosis
Key Insights
The FDA has approved Ocrevus ZUNOVO as the first and only twice-yearly, 10-minute subcutaneous injection for relapsing and primary progressive multiple sclerosis (search).
Ocrevus ZUNOVO offers an alternative administration method, potentially expanding treatment access to centers with IV constraints or limited infrastructure.
Backed by a decade of safety and efficacy data from Ocrevus IV, the new formulation demonstrated consistent suppression of relapse activity and MRI lesions in trials.
The U.S. Food and Drug Administration (FDA) has approved Ocrevus ZUNOVO (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (search) (RMS) and primary progressive multiple sclerosis (search) (PPMS), Roche announced. This marks the first and only twice-a-year, approximately 10-minute subcutaneous (SC) injection administered by healthcare professionals for both forms of multiple sclerosis (search). The approval aims to provide individuals living with MS more treatment options and greater flexibility.
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 (search). This approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs.”
Clinical Trial Data
The FDA approval is based on pivotal 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 the subcutaneous formulation of OCREVUS compared with OCREVUS intravenous (IV) infusion. The study demonstrated that SC injection was non-inferior to IV infusion based on OCREVUS levels in the blood, with consistent control of clinical (relapses) and radiological (MRI lesions) disease activity. Specifically, Ocrevus ZUNOVO demonstrated a 97% suppression of relapse activity and MRI lesions through 48 weeks, consistent with the IV formulation.
Safety and Efficacy
The safety profile of OCREVUS ZUNOVO was consistent with the well-established safety profile of OCREVUS IV, with the exception of injection reactions. Injection reactions were more frequently 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. Patient-reported outcomes indicated that over 92% of trial participants were satisfied or very satisfied with the SC administration of OCREVUS ZUNOVO.
Mechanism of Action
OCREVUS ZUNOVO combines OCREVUS with Halozyme Therapeutics’ Enhanze drug delivery technology. OCREVUS is a humanized monoclonal antibody designed to target CD20 (search)-positive B cells, believed to be key contributors to myelin and axonal damage in multiple sclerosis (search). The Enhanze drug delivery technology utilizes a proprietary recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily degrades hyaluronan in the subcutaneous space, increasing tissue permeability and allowing OCREVUS to be rapidly dispersed and absorbed into the bloodstream.
Implications for MS Treatment
This approval offers a significant advancement in the treatment landscape for multiple sclerosis (search). Natalie Blake, Executive Director of the MS Foundation, emphasized the importance of providing choices to address each person’s needs, stating, “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.” OCREVUS and OCREVUS ZUNOVO remain the only therapies approved for both RMS and PPMS, addressing a critical unmet need in PPMS treatment until the initial approval of OCREVUS.