The U.S. Food and Drug Administration (FDA) has granted full approval to Leqembi, an Alzheimer’s drug developed by Japanese pharmaceutical company Eisai and Massachusetts-based Biogen. This milestone approval paves the way for millions of patients to receive the medication known to slow the progression of the disease.
Improved Accessibility
The FDA’s decision to grant full approval to Leqembi is a significant leap forward in making this treatment more accessible. In January, the Centers for Medicare and Medicaid Services announced that they would cover a significant portion of the drug’s cost for patients, provided it received the FDA’s full approval. This will alleviate the financial burden of the $26,500 annual price tag for older adults covered by Medicare.
Slowing Alzheimer’s Progression
Clinical trials conducted on Leqembi demonstrated its ability to slow the rate of Alzheimer’s progression. While the drug cannot halt or reverse the disease, it has shown a 27% reduction in memory decline after 18 months of treatment. Furthermore, Leqembi significantly diminishes the accumulation of sticky beta-amyloid plaques in the brain, a hallmark of Alzheimer’s development.
Accelerated Approval and Safety
Previously, Leqembi received accelerated approval from the FDA in January based on its positive results in reducing amyloid plaques. Despite concerns regarding rare cases of brain bleeding, the FDA deemed the benefits of the drug to outweigh the risks at that time. However, with its recent full approval, Thursday’s announcement confirms Leqembi as a “safe and effective treatment” for Alzheimer’s patients, according to Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.
This FDA approval is a crucial advancement in the fight against Alzheimer’s disease. Leqembi offers hope to patients and their families by providing a proven method to slow the progression of this debilitating condition.