Analysis: Rival treatments may help justify FDA gamble with Biogen Alzheimer’s drug

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Data from clinical trials of three experimental Alzheimer's disease drugs expected to start emerging next year could help shed light on whether U.S. regulators were justified in their controversial approval of a Biogen Inc (BIIB.O) treatment without clear evidence that it works.

and Biogen's lecanemab - could give the medical community a better sense of whether Aduhelm is up to the job of slowing the ravages of Alzheimer's.

"If another independent study of a different anti-amyloid therapy shows a clear clinical benefit, it makes me much more comfortable with continued use of Aduhelm," he said. Large clinical trials of Aduhelm, known chemically as aducanumab, produced contradictory data, with one trial failing and another showing benefit. There was also a potentially serious brain swelling side effect.

"That's not to suggest that the next drug that lowers amyloid is a slam dunk or even gets approved. It may not," he said. Japan's Eisai completed enrollment last month in a pivotal 18-month study of lecanemab in symptomatic early Alzheimer's patients. The drug is also being studied in a large trial of people with evidence of amyloid in their brains who do not yet have symptoms of the disease.

 

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