The Food and Drug Administration (FDA) has granted full approval to the first Alzheimer’s drug that has been proven to moderately slow the progression of the disease. The approval is based on clinical trial data showing that Leqembi reduces cognitive decline by approximately 27% compared to a placebo in patients with early-stage Alzheimer’s.
Teresa Buracchio, the acting director of the FDA’s Office of Neuroscience, stated that this approval is a significant milestone, as it confirms that a drug targeting the underlying disease process of Alzheimer’s disease can provide clinical benefit.
In addition to the FDA approval, this decision also leads to a change in coverage by the Medicare program. Medicare will now broaden its coverage of the twice-monthly infusion of Leqembi, which costs $26,500 annually. Previously, coverage was limited to participants in clinical trials, but with FDA approval, potentially millions more patients will have access to the drug.
It is estimated that around 6.7 million people in the United States have been diagnosed with Alzheimer’s, and this number is expected to rise as the population ages. However, drugmaker Eisai anticipates that only 100,000 patients will be eligible and using the drug in the first three years on the market.
Medicare’s coverage decision also includes the requirement for providers to collect data through a patient registry to assess the drug’s real-world performance. The registry is currently not live, but CMS aims to make it easy for clinicians and patients to participate.
The registry will gather information on clinical diagnosis, amyloid test results, and evidence of adverse events, such as brain swelling or hemorrhage, to further evaluate the drug’s effectiveness and safety.
Although Medicare’s coverage decision has sparked controversy among industry and patient advocacy groups, as well as bipartisan lawmakers calling for unrestricted coverage, the registry requirement remains in place.
Leqembi received accelerated approval from the FDA in January based on evidence from clinical trials demonstrating its effectiveness in removing amyloid plaques, a hallmark of Alzheimer’s disease, from the brain. The drug is specifically approved for patients in the early stages of the disease with mild cognitive impairment or mild dementia and confirmed brain amyloid plaques.
Identifying eligible patients may present a challenge, but if successful, the approval of Leqembi could change the way Alzheimer’s disease is treated. Experts believe that patients may seek early diagnosis and treatment, leading to potential benefits in the earliest stages of the disease.
It is important to note that full approvals require more clinical evidence than accelerated approvals. While Leqembi has shown positive outcomes in slowing cognitive decline, it is accompanied by a risk of brain swelling or bleeding. During the trials, 13% of participants experienced these serious adverse events, resulting in three deaths.
Critics argue that Leqembi does not provide a significant clinically meaningful impact and that the differences observed between patients receiving the drug and those on the placebo are minimal. However, supporters emphasize that any delay in disease progression matters, as even a few additional months can make a difference for early-stage patients.
Dennis Selkoe, co-director of the Center for Neurologic Diseases at Brigham and Women’s Hospital in Boston and a consultant for Eisai, believes that Alzheimer’s patients and their families will be willing to take the risk associated with Leqembi. While it is not a cure, the drug has been shown to robustly slow cognitive decline, allowing patients to maintain their independence in daily activities.
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