Eli Lilly Alzheimer's Drug Delayed as FDA Plans Advisory Panel Meeting — Update

By Colin Kellaher

Eli Lilly on Friday said the Food and Drug Administration will hold an advisory committee meeting on its proposed Alzheimer's disease drug donanemab, likely delaying the agency's decision on whether to approve the drug for the memory-robbing disease.

Eli Lilly said the FDA has informed the company that it wants to further understand topics related to evaluating the safety and efficacy of donanemab in a pivotal Phase 3 study, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design.

The Indianapolis drugmaker said the FDA hasn't yet set a date for the meeting, but the timing of the expected FDA action on donanemab would be delayed beyond the first quarter.

The FDA was expected to approve donanemab early this year as a competitor to Leqembi from Eisai and Biogen after pushing the decision out from late last year.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective.

The agency usually follows the advice of its advisory committees, but it isn't bound by the recommendations. The FDA went against a negative vote when it approved Aduhelm, the ill-fated earlier Alzheimer's drug from Eisai and Biogen, in 2021.

Eli Lilly said that while it is unusual for an advisory committee to occur after the anticipated FDA action date, the agency convened similar meetings for the two other amyloid plaque-targeting therapies that it previously approved.

The company said the donanemab delay doesn't change its 2024 financial guidance.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

March 08, 2024 07:32 ET (12:32 GMT)

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