Eli Lilly Asks FDA to Approve Alzheimer’s Drug

Eli Lilly

LLY 1.17%

& Co. has begun asking U.S. health regulators to approve a new treatment for early-stage Alzheimer’s disease, hoping for a rare victory against a disease that has proved difficult for the pharmaceutical industry to tackle.

Indianapolis-based Lilly said Tuesday it began filing a rolling submission of study data and other information to the Food and Drug Administration for the experimental drug, donanemab.

The company expects to complete its application in the next several months, which could lead to an FDA decision in the second half of 2022, Lilly Chief Financial Officer

Anat Ashkenazi


Lilly’s decision to seek FDA approval of its experimental drug comes a few months after the agency approved the first new Alzheimer’s drug in nearly two decades,

Biogen Inc.’s

BIIB 0.86%


Both drugs are part of a new class of treatments designed to do what previously approved Alzheimer’s medicines failed to accomplish: slow the memory-robbing march of the disease. The new drugs target amyloid, a substance that forms plaques in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. The drugs are designed to clear amyloid.

Lilly’s drug, an intravenous infusion, modestly slowed the cognitive and functional decline of early-stage Alzheimer’s patients over 18 months in a small, midstage clinical study that had about 270 patients, Lilly reported earlier this year.

The drug also substantially cleared amyloid plaque in patients in the study.

Previously, Lilly didn’t expect to file an application for FDA approval of donanemab until 2023 because the company thought it needed more data from a continuing, late-stage study of the drug in about 1,500 patients. Results from that study are expected in 2023.

But Lilly’s plans changed after the FDA approved Biogen’s new Alzheimer’s drug. The FDA granted what is called an accelerated approval to Aduhelm, a type of FDA approval that is based on a drug’s effect on a surrogate measure rather than a clinical benefit to patients.

The FDA based its approval on Aduhelm’s ability to reduce amyloid plaque in the brain of Alzheimer’s patients. The FDA believes plaque reduction has the potential to provide clinical benefit to patients such as slowing the decline in cognitive function. It is requiring Biogen to demonstrate a clinical benefit in another study, in order for the drug to receive full approval.

Lilly said it also will seek an FDA accelerated approval for donanemab, based on the drug’s ability to reduce plaque in patients’ brains in the midstage study.

The FDA’s approval of Aduhelm was controversial because some doctors and FDA reviewers viewed the evidence of its benefit as insufficient. The FDA said it took into consideration that about six million Americans have Alzheimer’s and existing treatment options were limited. Uptake of the drug, however, has been slow as some doctors have been hesitant to prescribe it and some health insurers have declined to pay its hefty price.

Lilly is already taking steps to try to distinguish its own drug from Biogen’s The company said it plans to start a new late-stage study comparing donanemab head-to-head with Aduhelm. Researchers will assess which drug does a better job clearing amyloid plaque in the brain in early-stage Alzheimer’s patients. Results of the study could be ready in late 2022.

More on Alzheimer’s

Related WSJ coverage on the disease, selected by the editors.

Write to Peter Loftus at peter.loftus@wsj.com

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