FDA Approves Roche's Injectable Ocrevus for Multiple Sclerosis
核心洞察
The FDA has approved Roche's subcutaneous injectable version of Ocrevus for treating multiple sclerosis (搜索), offering a quicker 7-minute administration time.
The approval was based on the OCARINA II trial, demonstrating non-inferiority to the intravenous formulation regarding drug levels and similar safety profiles.
The injectable Ocrevus, to be available starting in October, expands treatment access by allowing administration in neurologist offices, avoiding specialized infusion centers.
Roche has received FDA approval for a subcutaneous injectable formulation of Ocrevus (ocrelizumab) for the treatment of multiple sclerosis (搜索) (MS). This new formulation offers a significantly reduced administration time of approximately 7 minutes, compared to the hours-long intravenous (IV) infusion. The approval is poised to broaden access to treatment and potentially fend off competition in the MS market.
The approval was primarily based on results from the OCARINA II trial, a late-stage study that compared the subcutaneous injection to the IV infusion. Data demonstrated that the injectable Ocrevus was non-inferior to the IV version, as measured by blood levels over 12 weeks. The safety and efficacy profiles were also found to be similar between the two formulations in patients with both relapsing multiple sclerosis (搜索) (RMS) and primary progressive multiple sclerosis (搜索) (PPMS).
"The subcutaneous version...is a 7-minute injection given twice a year, the same schedule as the previously approved intravenous infusion," Roche reported. This offers a considerable convenience for patients and healthcare providers.
David Jones, medical director at Roche subsidiary Genentech, indicated that the injectable formulation is expected to be available starting in October. A key advantage of the injectable Ocrevus is that it can be administered in neurologist's offices, eliminating the need for patients to travel to specialized infusion centers. This is particularly beneficial for patients in remote areas or those with limited access to infusion facilities.
Ocrevus is a monoclonal antibody designed to target CD20 (搜索)-positive B cells, which are believed to play a crucial role in the nerve cell damage associated with multiple sclerosis (搜索). Roche estimates that more than 2.8 million people worldwide are affected by MS. The IV formulation of Ocrevus generated sales of 6.38 billion Swiss francs ($7.54 billion) in 2023, highlighting its significance in Roche's portfolio.
The subcutaneous formulation, known as Tecentriq Hybreza, combines Ocrevus with Halozyme Therapeutics’ drug delivery technology. This technology facilitates rapid dispersion and absorption of the therapy into the bloodstream.
With over 350,000 individuals with multiple sclerosis (搜索) treated with Ocrevus IV globally, the introduction of the subcutaneous formulation marks a significant advancement in MS therapy, offering a more convenient and accessible treatment option for a broad range of patients.