Just how did the great new wonder drug for Alzheimer’s ever get approval? Despite garnering the headlines as the first breakthrough in countering the disease in more than 20 years, Aduhelm didn’t prove in any pre-approval clinical trials that it actually worked.
Instead, it reduces beta-amyloid protein clumps in the brain—and although these have been seen in Alzheimer’s patients, there’s no evidence they contribute to cognitive decline.
Despite this shortcoming, America’s drug regulator, the Food and Drug Administration (FDA), has approved the drug but has asked for further tests to demonstrate its effectiveness. Last November, ten of the 11 members of the agency’s expert advisory panel had recommended rejection because there was no evidence it worked.
For its part, Biogen, the drug’s manufacturer, estimates it could take nine years to come back with meaningful data. In the meantime, the drug—which is given as monthly intravenous doses—will be available to the American market at a cost of $56,000 a year.
(Source: The Economist, 2021; June 12, p14)
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