FDA Approves New Drug for Alzheimer’s Treatment
Thursday, July 6 marked a significant milestone in the fight against the debilitating Alzheimer’s disease, which currently has no cure. The United States Food and Drug Administration (FDA) has granted approval for the drug lecanemab-irmb, marketed as This Group, following successful clinical trials.
This is the first time an amyloid-beta antibody has received accelerated approval and mainstream approval for the treatment of Alzheimer’s disease. The FDA statement explains that the drug works by reducing the formation of amyloid plaques in the brain, a key characteristic of the disease. In January, the drug was initially approved for use in severe cases, but as of now, it is available to all American patients who require it, based on the observed efficacy during clinical trials.
Acting director of the Office of Neuroscience at the FDA’s Center for Drug Evaluation and Research, Teresa Buracchio, stated, “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s has shown clinical benefits in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.” The study involved 1,795 patients with mild Alzheimer’s disease who received a 10 milligram dose of Leqembi every two weeks. Results showed a statistically and clinically significant decline in cognition within 18 months compared to the placebo groups.
Now, the next step is to determine how many patients will have access to the drug. Medicare healthcare has announced that it will only reimburse Leqembi costs, amounting to over $26,000 per year, for those enrolled in a national registry that tracks possible side effects and long-term results. Some American family doctors have expressed concerns that access may be limited to only a few hundred thousand patients, despite the disease affecting 6.5 million individuals in the United States.
Joanne Pike, CEO of the Alzheimer’s Association, emphasized the importance of access to the drug, stating, “People living with this deadly disease deserve the opportunity to discuss and choose, with their physician and family, whether an FDA-approved treatment is right for them.” The Alzheimer’s Association has been advocating for broader coverage of the drug, but their request was denied by the agency.
During the study, several side effects of Leqembi were observed, including headaches, allergic reactions, and amyloid-related abnormalities. Temporary swelling and small bleeding spots in the brain were also reported. In severe cases, cerebral edema, seizures, and other neurological symptoms may occur. The FDA concluded that Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of Alzheimer’s disease, as that was the population studied during the clinical trials.
The approval of lecanemab-irmb marks a significant advancement in Alzheimer’s treatment. However, ensuring widespread access to the drug and managing its side effects will be crucial moving forward. As research continues, researchers hope to find more effective treatments and, ultimately, a cure for this devastating disease.