The U.S. Food and Drug Administration (FDA) has announced they will be examining an application by Eisai, a pharmaceutical company, under the accelerated approval pathway for the use of lecanemab to treat early Alzheimer’s disease. The FDA will make a decision by January 6, 2023. To backtrack and cover a few important topics about this monumental decision, this article will review what the FDA does in terms of approving new drugs/treatments, what Eisai is, and background on Alzheimer’s and how the treatment will help.
The FDA has a long approval process that begins with drug companies developing a drug or treatment in order to sell it to the public. Before that, they have to prove that the drug is safe enough to be used and tested in the first place. A team of many types of FDA scientists review company data regarding the safety and efficiency of the drug then approve it based on their findings. This is where Eisai seeks accelerated approval for their treatment. Accelerated approval means that the approval of the drug is expedited. It’s generally used for treatments that help with serious/life-threatening conditions and/or have a benefit over current available treatments. Even if a drug is granted accelerated approval, it’s conditional, meaning they must continue providing tests and data about the drug to the FDA in order to maintain its approval status.
Eisai is a Japanese pharmaceutical company headquartered in Tokyo, Japan. Earlier in 2021, they were granted accelerated approval for another Alzheimer’s treatment they co-developed with Biogen. Their current treatment, the application of lecanemab, is an antibody that targets amyloid plaques in the brains of people with early Alzheimer’s. This treatment was co-developed with Biogen and BioArtic.
What happens to the brain in Alzheimer’s though? With Alzheimer’s, the brain suffers extensive damage because a large number of neurons cease working, lose their connections to other neurons, and eventually die. The communication, metabolism, and repair processes that are essential to neurons and their networks are interfered with by Alzheimer's. A person with Alzheimer's disease gradually loses the ability to live and work independently over time. The illness is ultimately fatal. Research is still being done on what the exact cause is, but there are some characteristics of Alzheimer’s that have been identified and thought to be possible reasons behind it. One such characteristic is amyloid plaques. Numerous molecular variations of the beta-amyloid protein build up between neurons. It is created when a bigger protein known as amyloid precursor protein breaks down. Beta-amyloid 42 is one type that is thought to be particularly hazardous. This naturally occurring protein clumps up abnormally in the brain to produce plaques that build up between neurons and impair cell function. Lecanemab will be used to target these plaques and clear them in people with early Alzheimer’s so that there is not much progression of plaque buildup and they’re spared the progression of the disease.
The FDA’s decision to review Eisai’s application brings renewed hope to many patients with Alzheimer’s and their loved ones.
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