FDA-approved Alzheimer's drug Aduhelm is $50,000 too expensive

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Biogen has set the price of its Alzheimer's treatment Aduhelm at $56,000 a year. It is worth a lot less
The US Food and Drug Administration (FDA) approved a treatment to slow down the progression of Alzheimer's disease. The medication, developed by Biogen, will be marketed with the name Aduhelm for a list price of $56,000 a year.

This is the first drug approved for the disease—which affects about 6 million Americans and an estimated 44 million people worldwide—in 20 years, and it's already highly controversial.

Of the 10 independent experts called to share their assessment of the drug with the FDA, nine recommend not approving it, and one concluded its benefits were unclear. Of the two studies presented by Biogen, one showed no benefits, and the other modest ones. Both, however, had concerning side effects: About 40% of the clinical trial patients developed severe, and potentially life-threatening, brain swelling.

The agency nevertheless approved Aduhelm—which has the generic name aducanumab—albeit conditionally, pending the result of an upcoming large study on its effect. The study will have to be completed by 2030—longer than it would have likely required before approval because it will be hard to find patients willing to potentially receive a placebo when they have access to the actual medication.

A cost-benefit analysis

Aduhelm is supposed to reduce amyloid plaques, protein pieces that aggregate in clumps between the nerve cells of Alzheimer's patients. The plaques first attack the areas of the brain dedicated to memory and cognitive function, later expanding to other areas.

The FDA feels confident that the drug…
Annalisa Merelli
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