Recent News and Study Updates in MS Research
By Susan Wells Courtney
Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer
FDA Approves the First Biosimilar to Treat MS
On August 24, 2023, the United States Food and Drug Administration (FDA) approved Tyruko® (natalizumab-sztn), the first biosimilar to be approved for the long-term treatment of multiple sclerosis (MS). Marketed by Sandoz, Tyruko is a biosimilar to Tysabri® (natalizumab), a disease-modifying therapy for MS that was originally approved in 2004 and is given via IV infusion every four weeks. The advantages of having generic, biologic, and biosimilar products available often include greater accessibility to the medication, potential savings, and continued product development through competition.
According to the FDA, “A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.”
As with Tysabri, Tyruko is approved to treat relapsing forms of MS, which include clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary- progressive MS (SPMS). Because it is a biosimilar, Tyruko is given at the same dosage and via the same administration as Tysabri, while also carrying the same benefits and risks.
Tysabri’s benefits – when compared to placebo over a two-year period – include a 67% decrease in the number of relapses, a 92% reduction in lesions, and reductions in disability progression (42% and 54% over three and six months, respectively). Common potential side effects include headache and fatigue, infections such as upper respiratory tract infection (URTI) and urinary tract infection (UTI), as well as infusion reactions.
Tysabri is a monoclonal antibody that acts against a molecule involved in the activation and function of lymphocytes, which are immune system cells produced to fight infection and disease. It also acts against the passage of lymphocytes into the central nervous system (CNS). Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection caused by the JC virus. Given that natalizumab products increase the risk of PML, all such medications are required to have dedicated Risk Evaluation and Mitigation Strategy (REMS) programs.
Positive Results Shown in Study of 10-Minute Subcutaneous Administration of Ocrevus®
People with MS who take Ocrevus® (ocrelizumab) may be able to switch from twice-yearly intravenous infusions of two hours or longer to 10-minute subcutaneous (under the skin) injections, if the results of the recently completed OCARINA II trial prompt FDA approval of this easier and shortened route of administration. The injections would be given twice a year.
Approved by the FDA in 2017, Ocrevus is indicated for the treatment of relapsing forms of multiple sclerosis, including CIS, RRMS, and active SPMS. Further, it is the only medication approved to treat primary-progressive MS (PPMS).
Currently, Ocrevus is infused intravenously, with initial doses of 300 mg given over 2.5 hours or more two weeks apart, followed every six months by 600 mg typically administered over 3.5 hours or longer. Based on post-approval studies, the FDA sanctioned shortening the infusion time for the 600-mg dose to two hours or longer in people who had no prior serious infusion reaction with any previous Ocrevus infusion.
OCARINA II is a Phase III randomized trial conducted at study sites in several different countries. Its purpose is to assess the pharmacokinetics (or drug activity and availability), safety, and radiological and clinical effects of Ocrevus injected subcutaneously compared with Ocrevus infused intravenously in 236 patients with relapsing forms of MS or PPMS.
FDA Accepts New Drug Application for GA Depot Treatment
On August 7, 2023, Viatris and Mapi Pharma announced that the New Drug Application (NDA) for their product, GA Depot, had been accepted by the FDA for the treatment of relapsing forms of MS. The FDA’s decision on the approval of this treatment is scheduled for March 2024.
GA Depot is a long-acting injection version of Copaxone® (glatiramer acetate [GA]) and is designed to be administered as an intramuscular injection once every four weeks. FDA-approved in 1996, Copaxone is given via daily, or three-times weekly (depending on the dosage), subcutaneous self-injections. It is approved to treat relapsing forms of MS, including CIS, RRMS, and active SPMS, in adults.
Results from a Phase III clinical trial evaluating the efficacy, safety, and tolerability of GA Depot compared with placebo were used as support for the application to the FDA. More than 1,000 individuals with relapsing forms of MS participated in this international study and results include fewer injection-site reactions than with other GA products and a 30% reduction in annual relapse rate compared to placebo. A Phase II trial is currently evaluating GA Depot in people with PPMS.
For More Information
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