FDA Approves Roche's Ocrevus Zunovo for Multiple Sclerosis with Halozyme's Enhanze Technology
核心洞察
The FDA has approved Roche's Ocrevus Zunovo, a subcutaneous formulation for relapsing and primary progressive multiple sclerosis (搜索), utilizing Halozyme's Enhanze drug delivery technology.
Ocrevus Zunovo offers a twice-yearly, approximately ten-minute subcutaneous injection, providing greater flexibility for healthcare providers and patients based on individual needs.
The approval is based on the Phase III OCARINA II trial, which demonstrated non-inferior levels of Ocrevus in the bloodstream and comparable safety and efficacy to the intravenous formulation.
Roche has received FDA approval for Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq), a subcutaneous formulation utilizing Halozyme Therapeutics' Enhanze drug delivery technology, for the treatment of relapsing multiple sclerosis (搜索) (RMS) and primary progressive multiple sclerosis (搜索) (PPMS). This new formulation offers a twice-yearly, approximately ten-minute subcutaneous injection as an alternative to the intravenous formulation.
Levi Garraway, Roche'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.
Enhanze Technology Facilitates Subcutaneous Delivery
Ocrevus Zunovo combines Ocrevus with Enhanze drug delivery technology. Ocrevus is a humanized monoclonal antibody that targets CD20 (搜索)-positive B cells, which are implicated in causing damage to myelin and axons in multiple sclerosis (搜索). Enhanze technology utilizes recombinant human hyaluronidase PH20 (rHuPH20), an enzyme that temporarily breaks down hyaluronan in the subcutaneous tissue, increasing tissue permeability and enabling easier and more rapid dispersion and absorption of Ocrevus into the bloodstream.
Clinical Trial Results
The FDA's approval was based on the Phase III OCARINA II trial, which demonstrated non-inferior levels of Ocrevus in the bloodstream when administered subcutaneously compared to the intravenous formulation. The trial also confirmed a comparable safety and efficacy profile between the two approaches for individuals with RMS and PPMS. Exploratory outcomes of the trial revealed that Ocrevus Zunovo matched the intravenous version in suppressing relapse activity and MRI lesions through 48 weeks, with a 97% effectiveness rate for both measures. More than 92% of participants in the trial reported satisfaction with the subcutaneous administration of Ocrevus Zunovo.
Administration and Monitoring
After the first dose, treatment duration with Ocrevus Zunovo could be as short as 55 minutes. Patients are required to take premedications at least 30 minutes before each dose. After the first dose, patients will be monitored by their healthcare provider for a minimum of 60 minutes. For all subsequent doses, patients will be observed for at least 15 minutes post-injection. The most common adverse events associated with Ocrevus Zunovo were injection reactions, which were generally mild or moderate and did not lead to treatment withdrawal.