The US Food and Drug Administration has approved the first biosimilar to treat multiple sclerosis

Spanish

US Food and Drug Administration today consent Tyruko (natalizumab-sztn), the first biosimilar alternative to Tysabri injection (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated to stimulate and maintain clinical response and healing in adult patients with moderate to severe active Crohn’s disease with evidence of inflammation and who have had an inadequate response to or are unable to tolerate conventional CD therapies. and inhibitors of TNF-α (tumor necrosis factor, a substance in the body that causes inflammation).

Paul R. said: Lee, MD, PhD, director of the Division of Neurology 2 at the US Food and Drug Administration: “Biologics provide additional effective treatment options that have the potential to increase access to people with relapsing forms of multiple sclerosis.” for drug evaluation and research. “Today’s approval could have a beneficial impact on patients managing their disease.”

Tyruko is approved to treat the following relapsing forms of MS:

• Clinically isolated syndrome – first appearance of MS symptoms;
• Relapsing-remitting disease – a type of MS that occurs when patients experience episodes of new neurological symptoms followed by periods of stabilization. And
• Active secondary progressive disease – when, after a course of relapse and remission, patients experience progressive disability that worsens with persistent relapses.

Biological products include medicines to treat many serious diseases and chronic health conditions, including multiple sclerosis. A biosimilar is a biological product that closely resembles a biologic product already approved by the Food and Drug Administration (also called a reference product) and has no clinically meaningful differences from it. This means that patients can expect the same safety and efficacy from the biosimilar as they would from the reference product. All biological products are approved only after they meet the FDA’s strict approval criteria. The approval of Tyruko, a biosimilar to Tysabri (natalizumab), is based on evidence that showed no clinically meaningful differences between the two products in terms of safety, purity, and efficacy (ie, safety and efficacy).

“Today’s approval of the first biosimilar product indicated for the treatment of relapsing forms of multiple sclerosis reinforces the FDA’s long-term commitment to supporting a competitive market for biologics and ultimately empowering patients by helping increase access to safe, effective, high-quality medications at potentially lower prices. “The cost of treatment is very high,” said Sarah Yim, director of the Office of Therapeutic Biology and Biosimilars at the FDA’s Center for Drug Evaluation and Research.

MS is a chronic, inflammatory autoimmune disease that affects the central nervous system and disrupts communication between the brain and other parts of the body. It is among the most common causes of acquired neurological disability in young people and occurs more often in women than in men. For most people with MS, episodes of worsening function and new symptoms, called relapses, are initially followed by periods of recovery (remission). Over time, recovery may be incomplete, leading to progressive decline in function and increasing disability.

The prescribing information for natalizumab products (including Tyruko and Tysabri) contains a warning to inform healthcare professionals and patients of an increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually results in death or severe disability. Risk factors for developing PML include having antibodies to JC virus (antibodies to JC virus, a harmless virus normally carried by most humans), longer duration of treatment and prior use of immunosuppressants. These factors must be considered in the context of expected benefit when initiating and continuing treatment with natalizumab products, and healthcare providers should monitor patients and promptly discontinue treatment at the first sign or symptoms of PML.

Because of the risks of PML, natalizumab products are only available through a restricted drug distribution program, under the Risk Assessment and Mitigation Strategy (REMS). The REMS requires healthcare professionals who prescribe natalizumab products, and the pharmacies that distribute them, to be specifically REMS-certified, and that patients be enrolled in the REMS system. As part of the REMS requirements, prescribers must assess patients three and six months after the first infusion, every six months thereafter, and immediately and six months after stopping treatment.

Additional warnings in the prescribing information include risks related to herpes infections, thrombocytopenia (low platelet count), immunosuppression (increased risk of certain infections), and serious hypersensitivity reactions such as anaphylaxis and hepatotoxicity (major injury to the liver). The most common side effects associated with natalizumab products are headache and tiredness. Other common side effects are arthralgia (joint pain), urinary tract infection, lower respiratory tract infection, gastroenteritis (stomach flu), vaginitis (infection or inflammation of the vagina), depression, pain in extremities, abdominal discomfort, Diarrhea and rash.

The US Food and Drug Administration has granted approval for Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc.

Related information

###