The U.S. Food and Drug Administration (FDA) has granted full approval to lecanemab, an Alzheimer’s drug known as Leqembi, following an earlier accelerated approval. This marks a significant milestone, as it is the first drug to target the underlying disease process of Alzheimer’s and demonstrate clinical benefit.
Developed by Eisai and Biogen, Leqembi is the first medication shown to slow the progression of Alzheimer’s disease by addressing its fundamental biological mechanisms, including memory and cognitive decline.
Christopher A. Viehbacher, President and CEO of Biogen, expressed pride in being part of this breakthrough in Alzheimer’s treatment and emphasized the company’s commitment to making Leqembi accessible to eligible patients without delay.
Leqembi in 200mg and 500mg (Image: EISAI)
Eligibility criteria include individuals in the early stage of dementia and Alzheimer’s, specifically those with mild cognitive impairment. Timing is crucial for the drug to be effective, and patients must also exhibit evidence of amyloid in their brain, a key biomarker for Alzheimer’s.
Lecanemab acts as an antibody that removes existing plaque and prevents new plaque formation in the brain. This unique mechanism has raised hopes of potentially preventing Alzheimer’s. While the drug does not provide a cure or halt disease progression entirely, it has demonstrated the ability to slow the disease measurably, offering individuals additional time before experiencing further deterioration.
Dr. Joy Snider from Washington University in St. Louis highlighted the potential benefit of Leqembi, such as extending an individual’s ability to drive by six months to a year.
The downsides
However, Leqembi does have downsides, including the need for bi-monthly infusions and potential side effects such as brain swelling, infusion-related reactions, and headaches. Cost is also a concern, as the treatment is expected to be priced at approximately $26,500 for a year’s supply.
Nonetheless, the decision by the Centers for Medicare and Medicaid Services (CMS) to broadly cover Leqembi will improve affordability for many patients. Chiquita Brooks-Lasure, the head of CMS, hailed the FDA’s approval as welcome news for millions of affected individuals and their families.
The FDA’s approval of Leqembi comes in the wake of the controversy surrounding another Alzheimer’s drug, Aduhelm, also developed by Biogen and Eisai — Aduhelm’s approval in 2021 raised concerns due to its lack of demonstrated effectiveness and significant risks. Subsequently, the FDA restricted its use through updated labeling.
Alzheimer’s disease, an irreversible and progressive brain disorder that impacts memory, thinking skills, and daily functioning, affects more than 6.5 million Americans. The approval of Leqembi represents a crucial advancement in the ongoing battle against this debilitating disease, addressing its underlying processes rather than merely treating symptoms.
With further research and development, there is hope for continued progress in Alzheimer’s treatment and improved quality of life for patients and their families.