Transformation in Alzheimer's Treatment; U.S. Issues Approval for 'Lecanemab'

The U.S. Food and Drug Administration has issued its first full approval for a drug that slows the progression of Alzheimer's disease. The Japanese pharmaceutical company 'Eisai' is the manufacturer of the drug Lecanemab, which collaborates with the American company 'Biogen', the producer of the controversial Alzheimer's drug 'Aduhelm', for commercialization and marketing. These companies have stated that Lecanemab will cost approximately $26,050 per year. The FDA granted approval for Lecanemab based on data from a large study involving 1,800 patients. Clinical trials have clearly shown that the removal of amyloid from the brain has significant benefits for individuals with early Alzheimer's. In a phase three clinical trial, Lecanemab was able to delay cognitive decline and memory loss by five months compared to a placebo after 18 months of treatment. The drug is administered twice a month via intravenous injection. Lecanemab is prescribed for individuals with mild dementia and early Alzheimer's, and the FDA label instructs doctors not to prescribe Lecanemab without a test showing amyloid protein accumulation, a hallmark of Alzheimer's, in the patient. Lecanemab works by targeting beta-amyloid, the main component of amyloid plaques found in the brains of Alzheimer's patients. The FDA has included a warning on the Lecanemab label to raise awareness about side effects and at-risk populations. Side effects of this drug include amyloid-related imaging abnormalities (ARIA), which is a temporary swelling or bleeding in specific areas of the brain that usually resolves over time. This condition typically does not cause symptoms but can be serious in a small number of cases. The FDA also recommends genetic testing for patients before using the drug, as individuals with two copies of the known Alzheimer's gene may be at greater risk for the drug's side effects. Current drugs for Alzheimer's include donepezil, rivastigmine, galantamine, and memantine, which primarily improve symptoms and do not affect the disease process, offering limited clinical benefits. One of these drugs, Aduhelm, produced by Biogen, received approval in 2021 but has not been widely used due to disagreements over its effectiveness and cost. Aduhelm also targets amyloid protein, but its trials did not determine whether it could slow memory and thinking loss. Lecanemab has been more successful in demonstrating effectiveness and slowing disease progression. Although Lecanemab is not considered a cure, it gives individuals in the early stages of Alzheimer's more time to maintain their independence and engage in activities they enjoy. With longer use, Lecanemab may provide patients with more time to enjoy a normal life. According to the World Health Organization, over 55 million people worldwide currently suffer from dementia, with more than 60% living in low- or middle-income countries. Nearly 10 million new cases are identified each year. Dementia is a term for a range of diseases that affect memory, thinking, and the ability to perform daily activities, with Alzheimer's being the most common form. Alzheimer's is the fifth leading cause of death for individuals aged 65 and older in the U.S. It is estimated that about 1.5 million people in the U.S. are in the early stages of Alzheimer's. Many others—about five million—who have advanced disease are not eligible for Lecanemab. In Iran, the head of the Alzheimer's Association announced in April this year that about one million people suffer from various forms of dementia, including Alzheimer's. Masoumeh Salehi also stated that the age of onset for Alzheimer's in Iran has decreased, with individuals as young as 50 being affected. Some existing Alzheimer's drugs, including rivastigmine, are produced domestically in Iran. The head of the Iranian Alzheimer's Association stated that access to Iranian-made drugs for controlling Alzheimer's is also facing challenges due to shortages in the import of raw materials. In response to the question of whether Iranian-made drugs are effective, she said, 'God willing, they will be effective.' This report utilized sources such as the Associated Press, New York Times, Alzheimer's Association, World Health Organization, and Iranian media.