FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis

Core Viewpoint - Roche's OCREVUS ZUNOVO™ has received FDA approval for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), providing a new subcutaneous administration option that enhances treatment accessibility for patients [1][2][10]. Group 1: Product Details - OCREVUS ZUNOVO is the first and only twice-a-year, healthcare professional-administered subcutaneous injection for RMS and PPMS, taking approximately 10 minutes for administration [1]. - The approval is supported by a decade of safety and efficacy data from Ocrevus® IV, with over 350,000 patients treated globally [1]. - The Phase III OCARINA II trial demonstrated that OCREVUS ZUNOVO has a safety and efficacy profile consistent with the intravenous formulation, showing a 97% suppression of relapse activity and MRI lesions through 48 weeks [3][12]. Group 2: Clinical Trial Insights - The OCARINA II trial involved 236 patients and confirmed that the subcutaneous formulation is non-inferior to the intravenous version in terms of pharmacokinetics and disease activity control [11][12]. - Injection reactions were the most common adverse events, with 49% of participants experiencing reactions after the first injection, all classified as mild or moderate [4]. Group 3: Market and Patient Impact - The introduction of OCREVUS ZUNOVO aims to provide greater flexibility for healthcare providers and patients, addressing individual treatment needs and preferences [2]. - The new delivery method is expected to improve access to treatment for patients who may face challenges with intravenous administration [2][5]. Group 4: Company Commitment - Roche is committed to advancing innovative clinical research in multiple sclerosis, with over 30 ongoing clinical trials aimed at understanding the disease and improving treatment experiences [5][16]. - The company emphasizes the importance of developing new formulations to enhance patient experience and meet diverse administration preferences [6].