FDA OK’s New Alzheimer’s Drug Despite History
Dementia and Delirium

FDA OK’s New Alzheimer’s Drug Despite History

Last week the Food and Drug Administration approved Leqembi (lecanemab) for treatment of mild cognitive impairment and early Alzheimer’s Disease. Developed jointly by Eisai and Biogen, Lecanemab is a monoclonal antibody that is given in IV infusions once every two weeks. According to researchers, this drug reduces symptoms of Alzheimer’s and slows mental decline by 27% over 18 months of treatment. Although it does not stop the disease completely, it does slow it down by helping to remove accumulations of the beta-amyloid which doctors believe is the core of the disease.

Despite this promising data, many in the healthcare community have concerns following controversy around the FDA’s approval of another Alzheimer’s drug from Biogen, Aduhelm (aducanumab). Like Leqembi, Aduhelm is an antibody-based drug that fight dementia by targeting amyloid buildup.

Suspicious history with another Alzheimer’s drug

A congressional investigation last month revealed that the FDA failed to follow its own standards when approving Aduhelm. It worked far too closely with Biogen and seemingly wanted the drug approved from the get-go. In the end, the FDA gave Aduhelm early approval even though an independent evaluation committee unanimously voted against it.

To add even more fuel to this fire, Biogen accepted approval for the drug to be used in groups of people with Alzheimer’s who they hadn’t even studied at all. Biogen also planned to sell the drug at the absurd price of $56,000 a year. This high cost was key in pushing the large spike in Medicare premiums in 2022.

With all this in mind, Biogen, instead of stepping back for a reset, charged ahead. They planned to spend billions to manufacture and sell a story to the public that this was a ground breaking drug and we should thank them for it.

Since the congressional report revealed all of this, Biogen suffered major publicity whiplash and cut the price of Aduhelm by half. Suspicion still surrounds the drug and many major health networks do not offer it.

Promising, but not perfect

This has all had a significant impact on the release of the new Biogen drug, Leqembi (lecanemab). The FDA is more restrictive in specifying who should take the drug (only people with early Alzheimer’s). They also are requiring more specific labeling and guidance on the risks of brain swelling, brain bleeding, and of taking blood thinners while on the drug. None of this was done with Aduhelm at first, despite the known risks.

Leqembi does appear to be safer and more effective than Aduhelm according to research so far. However, many doctors who regularly treat dementia are still skeptical. Studies of Leqembi are not complete, and doctors need to weigh potential benefits against a multitude of risky side effects. Medicare knows this, too, and, as with Aduhelm, will not cover the cost yet.

References
  1. Reardon, S. (2023). FDA approves Alzheimer’s drug lecanemab amid safety concerns. Nature, 613, 227–228.
  2. Lovelace Jr., B. (2023). FDA approves new Alzheimer’s drug that appears to slow disease. NBC News. Retrieved from https://www.nbcnews.com/health/health-news/fda-approves-alzheimers-drug-appears-slow-disease-rcna62928 on 1/10/23.
  3. Belluck, P. (2022). Congressional Investigation into Alzheimer’s Drug Aduhelm Faults the F.D.A. and Biogen. N.Y. Times. Retrieved from https://www.nytimes.com/2022/12/29/health/alzheimers-drug-aduhelm-biogen.html on 1/11/23.
  4. Christensen, J. (2022). House investigation says FDA approval process of Alzheimer’s drug was ‘rife with irregularities’. CNN. Retrieved from https://www.cnn.com/2022/12/29/health/biogen-aduhelm-alzheimers-drug-investigation/index.html on 1/12/23.
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