FDA Approves Subcutaneous Ocrevus Zunovo for Multiple Sclerosis
核心洞察
The FDA has approved Ocrevus Zunovo, a subcutaneous formulation of ocrelizumab, for all forms of multiple sclerosis (搜索), including relapsing MS and primary progressive MS.
Ocrevus Zunovo offers a quicker 10-minute injection compared to the 2-4 hour intravenous infusion required for the original Ocrevus formulation.
Approval was based on the OCARINA II trial, demonstrating similar efficacy and safety profiles between subcutaneous and intravenous formulations of ocrelizumab.
The FDA has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), a subcutaneous formulation of Ocrevus (ocrelizumab), for the treatment of adult patients with multiple sclerosis (搜索) (MS), including relapsing forms of MS and primary progressive MS (PPMS (搜索)). This approval offers a new, more convenient administration option for patients, reducing treatment time from hours to minutes.
Ocrevus Zunovo: A Faster Route to Treatment
Ocrevus Zunovo provides the same therapeutic benefits as the original intravenous (IV) formulation of Ocrevus but is administered via a 10-minute subcutaneous injection. This is a significant improvement over the two- to four-hour IV infusion required for Ocrevus. The new formulation contains ocrelizumab, which targets the CD20 (搜索) protein on B-cells to reduce inflammation, and hyaluronidase, which enhances absorption under the skin.
Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of global product development, stated that Ocrevus Zunovo offers patients and providers another option for receiving Ocrevus, building on a decade of robust safety and efficacy data. The approval may offer greater flexibility for healthcare providers and people living with multiple sclerosis (搜索), based on their individual treatment needs.
Clinical Evidence: OCARINA II Trial
The FDA's decision was supported by data from the OCARINA II Phase 3 trial (NCT05232825), which compared the pharmacokinetics, safety, and efficacy of subcutaneous Ocrevus Zunovo to intravenous Ocrevus in 236 adults with relapsing MS and PPMS (搜索). The trial demonstrated that both formulations resulted in similar levels of ocrelizumab in the bloodstream and comparable reductions in B-cell levels.
After 48 weeks, the majority of patients in both groups were free from relapses and showed no signs of MRI disease activity. Approximately 92% of patients reported satisfaction with the subcutaneous administration, and 90% found it convenient. While the safety profiles were similar, injection reactions were more common with Ocrevus Zunovo, reported in 49% of patients after the first injection, though these were generally mild to moderate.
Implications for MS Treatment
The approval of Ocrevus Zunovo addresses several challenges in MS treatment. The shorter administration time and subcutaneous route may improve access to treatment, particularly for patients in centers with limited IV infrastructure. It also offers greater convenience and flexibility for both patients and healthcare providers.
Natalie Blake, executive director of the Multiple Sclerosis (搜索) Foundation, emphasized the importance of providing choices to address each person’s needs, noting that the new method of delivery offers an additional option for those who need flexibility in the route of administration or treatment time. The availability of subcutaneous Ocrevus Zunovo represents a significant step forward in enhancing the patient experience and expanding access to effective MS therapy.