The U.S. Food and Drug Administration will expedite its review of Eisai Co Ltd's and Biogen Inc's experimental Alzheimer's drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.
experimental Alzheimer's drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.
The FDA controversially approved Aduhelm in June last year, although only one of two late-stage trials showed it helped slow cognitive decline. The FDA's own panel of outside experts had advised against approval.Biogen subsequently slashed its price for the drug to $28,000 per year from an initial $56,000. But Medicare, the U.S.
Shares of the Japanese company jumped on the news, gaining more than 4% in Tokyo trade and making Eisai the second-biggest gainer on the benchmark Nikkei 225Under the FDA's accelerated pathway, lecanemab needs to show it can effectively interfere with underlying changes that lead to Alzheimer’s dementia, rather than prove any impact on cognition. Such a "biomarker" would be the level of amyloid proteins in the brain.
Eisai said it would have results from a large, Phase 3 trial of lecanemab available this fall, which will answer the question of whether the drug has an impact on cognitive ability.
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