Is Natalizumab on the market?

Natalizumab is a recombinant humanized IgG4κ monoclonal antibody that binds to α4-integrin. Although natalizumab was initially approved by the U.S. Food and Drug Administration (FDA) in 2004 to treat multiple sclerosis (MS) , the drug was withdrawn from the market after multiple reports of fatal progressive multifocal leukoencephalopathy (PML). In 2006, the FDA reintroduced the drug to the multiple sclerosis market. In January 2008, the FDA further approved natalizumab for the treatment of Crohn's disease. Natalizumab is sold under the trade name Tysabri.

On August 24, 2023, Natalizumab-sztn, the first biosimilar, was approved by the FDA. Natalizumab was approved by the European Commission on September 22, 2023. The biosimilar is under the trade name of Tyruko. Studies show that natalizumab is effective in treating relapsing-remitting multiple sclerosis. However, due to its safety risks, it should be used only in patients who truly need the drug because their disease is not adequately controlled by at least one other disease-modifying therapy or is rapidly worsening.

The most common side effects associated with natalizumab are headache and fatigue, and other common side effects include joint pain, urinary tract infection, lower respiratory tract infection, gastroenteritis (stomach flu), vaginitis (vaginal infection or inflammation), depression, pain in the extremities, abdominal discomfort, diarrhea, and rash.

Natalizumab's original patent drug is not marketed in the country and cannot be included in medical insurance. Currently, the generic drug natalizumab on the market overseas may cost more than 8,000 US dollars per box (the price may fluctuate due to exchange rates), which is very expensive. For more drug information and specific prices, please consult Yaode Medical Consultant.