Press Release
☷FDA Approves First Biosimilar to Treat Multiple Sclerosis
Food and Drug Administration ( By Press Release office)
Aug 25,2023
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Hey , guess what? The U . S . Food and Drug Administration just approved this new drug called Tyruko . It ' s a biosimilar to Tysabri and it ' s gonna be used to treat adults with relapsing forms of multiple sclerosis . But that ' s not all , it can also help with Crohn ' s Disease for those who haven ' t had success with other treatments . Pretty cool , right? According to the FDA , this approval could really make a difference for patients dealing with these conditions . So yeah , Tyruko is gonna be used for a few different kinds of MS , like when someone has a single occurrence of symptoms or when they have episodes followed by periods of stability . And it can even help with progressive disease . Just so you know , biosimilars are basically the same as the original drug , so you can expect the same results . The FDA made sure of it . They ' ve done all the tests and studies to show that Tyruko is just as safe and effective as Tysabri . This is a big deal because it gives patients more options and could potentially lower costs . So it ' s a win - win situation . There ' s a warning on the information for natalizumab products ( like Tyruko and Tysabri ) about a higher risk of a brain infection called progressive multifocal leukoencephalopathy ( PML ) . PML can be deadly or cause severe disability . Some factors that increase the risk of getting PML are having antibodies to the JC virus , being on treatment for a long time , and having used immunosuppressants before . Doctors should think about these risks when deciding if someone should start or keep using natalizumab products , and they should watch out for signs of PML and stop treatment right away if they see them . The information for natalizumab products also warns about other risks , like herpes infections , low blood platelet count , higher risk of certain infections , serious allergic reactions , and liver damage . The most common side effects of natalizumab products are headaches and feeling tired . Other common side effects include joint pain , urinary tract infections , respiratory infections , stomach flu , vaginal infections or inflammation , feeling down , pain in arms or legs , stomach discomfort , diarrhea , and rashes . The FDA has given approval to Sandoz Inc . for Tyruko , which is the first biosimilar to Tysabri ( natalizumab ) . Because of the risks of PML , natalizumab products can only be given out through a special program that makes sure the right people get them . Doctors and pharmacies have to be certified in this program , and patients have to be enrolled too . As part of the program , doctors have to check on patients three and six months after they start using natalizumab , and then every six months after that . They also have to check on them right away and six months after they stop using it .
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