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For the management of multiple sclerosis, the FDA has granted approval to the first biosimilar (Natalizumab-sztn).
According to a recent report published on 24 August 2023, the U.S. Food and Drug Administration (FDA) has approved Tyruko (Natalizumab-sztn), marking the debut of the first biosimilar medication to combat relapsing forms of multiple sclerosis. This green light represents a pivotal stride in enhancing treatment accessibility for adults grappling with the condition. Multiple sclerosis is a chronic, inflammatory autoimmune ailment affecting the central nervous system, impairing communication between the brain and other body parts. It ranks among the leading causes of acquired neurological disability among young adults, with a higher incidence in women than men.
For most multiple sclerosis patients, relapses with worsening function and new symptoms are initially followed by remissions. Nevertheless, with time, the recovery process may not be full, potentially resulting in gradual deterioration of function and an escalation in disability. Tyruko, mirroring the properties of Tysabri (Natalizumab), is authorized not only for the treatment of relapsing multiple sclerosis in adults but also for inducing and sustaining clinical response and remission in adult patients experiencing moderately to severely active Crohn’s disease with inflammation evidence.
This approval is particularly beneficial for those who have either not responded adequately to traditional Crohn’s disease therapies or cannot tolerate them, along with tumor necrosis factor-alpha (TNF-α a substance triggering inflammation) inhibitors. Biosimilar drugs present an opportunity to expand treatment choices, potentially improving accessibility for individuals coping with relapsing forms of multiple sclerosis. This FDA approval stands to make a substantial impact on patients managing their condition.
Tyruko's approval extends to various relapsing multiple sclerosis forms, including relapsing-remitting disease, clinically isolated syndrome, and active secondary progressive illness. These forms encompass a range of multiple sclerosis manifestations, from isolated symptom onset to periods of symptom stability and gradual disability progression following relapses. Biological products, spanning treatments for numerous severe illnesses and chronic conditions like multiple sclerosis, underpin the biosimilar category. Biosimilars are biological products highly resembling and not clinically different from already FDA-authenticated biological products (called reference products).
This ensures patients can anticipate the same level of safety and effectiveness from biosimilars as they would from reference products. All biological products, biosimilars included, must meet the FDA's stringent approval criteria. Tyruko's approval, as a biosimilar to Tysabri, hinges on evidence demonstrating no clinically meaningful differences between the two in terms of potency, purity, and safety. For biological products, FDA is commited to fostering a competitive marketplace. This move empowers patients by enhancing access to safe, effective, and high-quality medications, potentially at lower costs.
For Natalizumab products, encompassing Tyruko and Tysabri, the prescribing information carries a boxed warning regarding the heightened hazard of progressive multifocal leukoencephalopathy (PML), a viral brain infection often resulting in severe disability or mortality. Factors contributing to PML risk encompass the presence of anti-JC virus antibodies, prolonged therapy, and prior use of immunosuppressants. Healthcare providers should weigh these factors against anticipated benefits when initiating and continuing Natalizumab product treatments. Vigilant patient monitoring is crucial, with immediate discontinuation at any sign or symptom suggesting PML.
Due to PML risks, Natalizumab products are accessible solely through a controlled drug distribution program governed by a risk evaluation and mitigation strategy (REMS). This REMS mandates that healthcare professionals prescribing Natalizumab products, as well as pharmacies dispensing them, must hold special certification within the REMS, with patients also enrolled in the program. As a component of the REMS prerequisites, healthcare providers need to assess patients at three and six months following the initial infusion, followed by semi-annual evaluations and checks immediately and six months post-treatment discontinuation.
The prescribing information encompasses additional warnings about herpes infections, thrombocytopenia (low blood platelet count), immunosuppression (heightened infection risk), severe hypersensitivity reactions like anaphylaxis, and hepatotoxicity (significant hepatic impairment). Fatigue and headache are the most frequent adverse effects linked with Natalizumab products. Other common side effects encompass lower respiratory tract infections, rash, diarrhea, joint pain, urinary tract infections, gastroenteritis, vaginitis, depression, extremity pain, and abdominal discomfort.
US-FDA
FDA Approves First Biosimilar to Treat Multiple Sclerosis
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