Lecanemab appeared to slow down cognitive decline in people with early Alzheimer's, though some experts question its real-world benefits.
Lecanemab and other anti-amyloid drugs are also known to increase the risk of brain bleeding. Cases of this adverse effect appear to be typically mild, with most patients not even developing symptoms. But there have been at least three reported deaths linked to brain bleeding following the use of lecanemab, with the concurrent use of blood thinners possibly having contributed to at least
. The FDA’s approval will require a label warning of this increased risk, though it also notes that serious and life-threatening events are rare.Lecanemab, which will be sold as Leqembi, isn’t the first anti-amyloid drug to be approved by the FDA. In June 2021, the FDAthe drug Aduhelm, also developed by Biogen and Eisai. The trial data supporting Aduhelm’s approval was even more ambiguous than in lecanemab’s case, and the agency was accused of pushing through a possibly worthless drug.
Aduhelm and lecanemab were both greenlit under the FDA’s accelerated approval pathway. This designation allows companies to speed up a drug’s approval by only having to present indirect evidence that it will be clinically meaningful to patients, though they are required to eventually provide clear data of its benefits. Unlike with Aduhelm, FDA did not call for an outside advisory committee to review the evidence for lecanemab prior to its approval.
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