FDA panel backs Eli Lilly’s Alzheimer’s drug

A federal advisory panel on Monday voted in favor of recommending Eli Lilly’s new drug that is under consideration for its potential to slow the progression of Alzheimer’s disease.

The Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee met Monday to discuss Eli Lilly’s donanemab.

The committee’s voting members were asked to vote on the question, “Do the available data show that donanemab is effective for the treatment of Alzheimer’s disease in the population enrolled in the clinical trials with mild cognitive impairment and mild dementia?”

The drug works by binding to and removing amyloid plaques, which are believed to damage brain cells and contribute to cell death.

In data presented to the committee, representatives for Eli Lilly noted a 29 percent slowing in disease progression compared to a placebo group when rated by the Clinical Dementia Rating Scale—Sum of Boxes scoring system. This was observed after 76 weeks of administration.

When scored using the Integrated Alzheimer’s Disease Rating Scale (iADRS) assessment, a 22 percent slowing in disease progression was observed compared to the placebo group within the same time frame.

All 11 voting members of the committee voted yes on the question of whether the available data supported donanemab as an effective treatment for mild dementia. Several members said they voted yes as they felt there was an acceptable level of risk when compared to the data.

Some members, however, expressed concern with the lack of Black and Hispanic participants in the trial.

“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.

“Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety,” Pike added. “This will lead to possibilities for combination therapies that address the complexity of the disease.”

The progressive consumer rights group Public Citizen spoke out against approving donanemab following the committee’s vote. The group argued in a testimony that the results of the study, particularly the results using the iADRS scale, indicated the drug was unlikely to be “clinically meaningful.”

“The advisory committee meeting was very disappointing. The essential issue was not the specifics of the potential prescribing information for donanemab but whether the drug should be approved to begin with,” Robert Steinbrook, director of Public Citizen’s Health Research Group, said in a statement following the vote.

The FDA has approved two other Alzheimer’s treatments in recent years, although one is no longer being sold. The agency approved Biogen’s Aduhelm in 2021, making it the first Alzheimer’s treatment approved in 20 years. However, evidence that the drug actually worked was lacking, and Biogen ultimately gave up ownership of Aduhelm earlier this year.

Last year, the FDA approved Leqembi, also made by Biogen, after it was shown to moderately slow the progression of Alzheimer’s.