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FDA to delay decision on Eli Lilly Alzheimer's drug for second time

March 8, 2024 7:29 AM
(Updated - March 8, 2024 10:04 AM EST)

Investing.com -- Eli Lilly (NYSE: LLY) has said that a decision from U.S. drug regulators on whether to approve its much-anticipated treatment for early Alzheimer's disease will be delayed beyond the first quarter.

It marks the second time that the Food and Drug Administration has postponed a decision on the therapy, known as donanemab, since Lilly unveiled clinical trial data last year which the company said suggested that it was safe and effective.

The FDA told Lilly that it plans to convene an advisory board to "further understand topics" related to the drug. According to the firm, the date for the committee meeting has yet to be set by the FDA.

"While the delay and pursuant advisory committee for donanemab is surprising, especially given how late they were announced, we believe FDA is acting with an abundance of caution convening an advisory committee," analysts at BMO Capital Markets said in a note.

In a statement, Lilly Executive Vice President Anne White said that the business remains confident in donanemab's potential to offer "very meaningful" benefits to people suffering from the early stages of Alzheimer's disease, an affliction that the CDC refers to as the most common form of dementia.

Analysts at Truists said the results from the donanemab trial were "compelling" and showed "clinically meaningful outcomes."

Shares in Lilly edged lower in early U.S. trading on Friday.

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