The FDA has approved Roche's Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) as the first and only twice-yearly, 10-minute subcutaneous (SC) injection for treating both relapsing multiple sclerosis (RMS) and primary-progressive multiple sclerosis (PPMS). This regulatory action stems from the Phase III OCARINA II trial, highlighting a significant advancement in MS treatment by offering a more convenient administration route without compromising efficacy or safety.
The global multicenter, randomized OCARINA II study compared the pharmacokinetics, safety, and clinical and radiological efficacy of the SC formulation of Ocrevus to the intravenous (IV) infusion. The trial involved 236 patients with RMS or PPMS. The primary endpoint focused on demonstrating non-inferiority of the SC formulation compared to the IV version, based on Ocrevus levels in the blood. Secondary endpoints included consistent control of clinical and radiological disease activity.
Key Findings from OCARINA II
Results indicated that Ocrevus Zunovo effectively suppressed relapse activity and MRI lesions by 97% over 48 weeks, mirroring the performance of the IV formulation. Furthermore, 92% of trial participants reported satisfaction or high satisfaction with the SC administration method.
Levi Garraway, MD, PhD, chief medical officer, head of global product development at Roche, 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. This approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis, based on their individual treatment needs."
Safety and Tolerability
Injection reactions were observed in 49% of trial participants after the first injection, ranging from mild to moderate, with no instances leading to treatment withdrawal. Reported adverse events (AEs) included pruritus, rash, urticaria, erythema, bronchospasm, throat irritation, oropharyngeal pain, dyspnea, pharyngeal or laryngeal edema, flushing, hypotension, pyrexia, fatigue, headache, dizziness, nausea, tachycardia, and anaphylaxis. Roche advises that infusion reactions can occur up to 24 hours post-infusion. Life-threatening or fatal AEs, such as bacterial, viral, parasitic, and fungal infections, have been reported in patients receiving Ocrevus.
Impact on MS Treatment Landscape
According to the National Multiple Sclerosis Society, approximately one million people in the United States have been diagnosed with MS, and an estimated 2.8 million people worldwide live with some form of MS. Natalie Blake, executive director of the MS Foundation, emphasized the importance of treatment options, stating, "People are living longer with chronic illnesses and with fewer disabilities because of the extensive progress that has been made in the development of medicines that can slow their progression. But still, not everyone has access to these medicines. 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."
