FDA Sets June 10 Advisory Panel Meeting on Eli Lilly Alzheimer's Drug

By Colin Kellaher

Eli Lilly on Tuesday said the U.S. Food and Drug Administration has set June 10 as the date for its advisory committee meeting on the drugmaker's proposed Alzheimer's disease drug donanemab.

An FDA decision on whether to approve donanemab for the memory-robbing brain disorder had been expected in the first quarter, but Eli Lilly in early March said the agency would convene an advisory panel to further understand topics related to evaluating the safety and efficacy of the drug in a pivotal Phase 3 study.

Eli Lilly's chief scientific officer, Daniel Skovronsky, said during the company's earnings conference call last week that the Indianapolis company remains confident in donanemab's potential "to offer very meaningful benefits to patients."

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 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.

After Eli Lilly announced the FDA's plans for the advisory committee meeting, analysts said they still expect the agency to approve the drug.

The FDA 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.

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

(END) Dow Jones Newswires

May 07, 2024 10:55 ET (14:55 GMT)

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