Saturday, August 26, 2023

New drug approved to treat Multiple sclerosis (MS)

Monoclonal antibody treatment biosimilar drug approved for Multiple Sclerosis. 
The U.S. Food and Drug Administration (FDA) has recently approved a biosimilar medication called Tyruko (natalizumab-sztn). This biosimilar is the first of its kind for Tysabri (natalizumab) injection, and it's intended for the treatment of adults with various forms of multiple sclerosis (MS). Tyruko is also approved for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's Disease (CD) who have not responded well to conventional CD therapies and inhibitors of TNF-α.
Paul R. Lee, M.D., Ph.D., the director of the Division of Neurology 2 in the FDA's Center for Drug Evaluation and Research, stated that biosimilar medications like Tyruko provide additional effective treatment options that could improve access to care for individuals with relapsing forms of multiple sclerosis. He emphasized that this approval could significantly benefit patients managing their disease.
Tyruko is authorized for the treatment of the following forms of MS:
1. Clinically isolated syndrome – which involves a single, initial occurrence of MS symptoms.
2. Relapsing-remitting disease – a type of MS characterized by episodes of new neurological symptoms followed by periods of stability.
3. Active secondary progressive disease – occurring after a relapsing-remitting course, where patients experience gradual disability worsening along with continued relapses.

A biosimilar is a biological product that closely resembles and does not have clinically significant differences from a reference biological product that has already been approved by the FDA. This implies that patients can expect similar safety and effectiveness from the biosimilar as they would from the reference product. All biological products, including biosimilars, must meet the FDA's stringent approval standards. The approval of Tyruko as a biosimilar to Tysabri is based on evidence that demonstrates there are no clinically meaningful differences between the two products in terms of safety and effectiveness.

Sarah Yim, M.D., the director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, highlighted that this approval aligns with the FDA's commitment to fostering competition in the marketplace for biological products. It aims to empower patients by increasing access to high-quality medications that could potentially come at a lower cost.
Multiple sclerosis (MS) is a chronic autoimmune disease that affects the central nervous system, disrupting communication between the brain and the body. It's a common cause of neurological disability in young adults, with a higher prevalence in women. The disease is characterized by episodes of worsening function followed by periods of recovery, although over time, this recovery may be incomplete, leading to increased disability.

Notably, both Tyruko and Tysabri (natalizumab products) come with a boxed warning regarding the increased risk of progressive multifocal leukoencephalopathy (PML), a severe viral brain infection that can lead to death or severe disability. Risk factors for PML development include factors like the presence of anti-JCV antibodies, longer therapy duration, and previous use of immunosuppressants. To manage these risks, natalizumab products are available through a restricted drug distribution program under a risk evaluation and mitigation strategy (REMS). Healthcare providers must be certified in the REMS, and patients need to be enrolled as well. Monitoring and evaluation are crucial throughout treatment.

The Prescribing Information for these products also includes warnings about other potential risks, such as herpes infections, low blood platelet count, immunosuppression, hypersensitivity reactions, and liver injury. Common side effects associated with natalizumab products include headache, fatigue, joint pain, urinary tract infections, respiratory infections, gastrointestinal issues, vaginal infections, depression, extremity pain, abdominal discomfort, diarrhea, and rash.
The FDA granted approval of Tyruko, the biosimilar to Tysabri (natalizumab), to Sandoz Inc.

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