FDA set to make decision on experimental Alzheimer’s drug this week

Alzheimer Drug Probe
FILE – A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. The FDA’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday, Dec. 29, 2022, as congressional investigators called the process “rife with irregularities.” (AP Photo/Manuel Balce Ceneta, File) Manuel Balce Ceneta/AP

FDA set to make decision on experimental Alzheimer’s drug this week

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The Food and Drug Administration is expected to decide by Friday whether to grant accelerated approval for Eisai and Biogen’s experimental Alzheimer’s drug, lecanemab.

Results from a large study earlier this year found that lecanemab slowed the rate of cognitive decline among patients in the early stages of Alzheimer’s, boosting its chances for approval, though reports of serious adverse events with trial patients, including brain swelling and bleeding, have raised questions about its safety.

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“If lecanemab is approved by the FDA under the Accelerated Approval Pathway, Eisai will do its best to make lecanemab available as soon as possible,” a spokesperson for Eisai said in a statement to the Washington Examiner. “Eisai aims to file a Supplemental Biologics License Application for traditional approval in the U.S. soon and to file marketing authorization applications in Japan and Europe by the end of Eisai’s fiscal year 2022, which ends on March 31, 2023.”

The accelerated approval pathway, which the FDA first instituted in 1992, allows for faster approvals for drugs for serious conditions that fill an “unmet medical need.”

Lecanemab has been one of the first experimental drugs that has had success in slowing the progression of the disease, which has no known cure, offering hope for the over 6 million people in the United States that are living with it and their families.

However, two deaths among trial patients have tempered enthusiasm surrounding the drug, which targets a type of plaque in the brain made up of the protein beta-amyloid that is believed to cause memory and cognitive problems.

Eisai told the Washington Examiner in November that available safety data suggest that the drug is not associated with an “increased risk of death overall or from any specific cause.”

The FDA’s decision is expected a week after House Democrats criticized the FDA’s accelerated approval process for Biogen’s controversial Alzheimer’s drug, Aduhelm. A joint report by Democratic staff on the House Oversight and Energy and Commerce committees found that the FDA’s collaboration with Biogen was “atypical” and failed to adhere to the agency’s protocol for interacting with drug companies, ultimately resulting in Aduhelm receiving approval despite concerns over its effectiveness.

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Aduhelm became the first new therapy for Alzheimer’s in nearly two decades to receive approval last year, despite the FDA’s advisory committee voting against approving the drug. It has since faced challenges on the market, with an initial price tag of $56,000 annually (later cut by Biogen) and Medicare significantly limiting coverage of the drug.

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