A federal advisory panel voted Monday in favor of recommending Eli Lilly's new drug, which is currently being considered for its potential to slow the progression of Alzheimer's disease.
The Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drug Advisory Committee met Monday to discuss Eli Lilly's donanemab.
The voting members of the committee were asked to vote on the question: “Do available data show that donanemab is effective for the treatment of Alzheimer's disease in the population enrolled in the mild cognitive impairment and mild dementia clinical trials? “
The drug works by binding to and removing amyloid plaques, which are thought to damage brain cells and contribute to cell death.
In data presented to the committee, Eli Lilly representatives noted a 29 percent slowdown in disease progression compared to a placebo group, as assessed 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), a 22 percent delay in disease progression was observed within the same time frame compared to the placebo group.
All eleven voting members of the committee voted yes when asked whether available data support donanemab as an effective treatment for mild dementia. Several members said they voted 'yes' because they felt there was an acceptable level of risk compared to the data.
However, some members expressed concern about the lack of Black and Hispanic participants in the trial.
“A future with more approved treatments for Alzheimer's disease is a huge advancement for people who qualify for these medications. Progress is being made in treatment,” 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 opportunities for combination therapies that address the complexity of the disease.”
Progressive consumer rights group Public Citizen spoke out against donanemab's approval after the committee vote. The group argued in testimony that the study's results, specifically those 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 details 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 after the vote.
The FDA has approved two other treatments for Alzheimer's disease in recent years, although one is no longer sold. The agency approved Biogen's Aduhelm in 2021, making it the first treatment approved for Alzheimer's disease in 20 years. However, evidence that the drug actually worked was lacking and Biogen finally relinquished ownership of Aduhelm earlier this year.
Last year, the FDA approved Leqembi, also made by Biogen, after it was shown to slightly slow the progression of Alzheimer's disease.
