A federal advisory panel voted Monday to recommend Eli Lilly’s new drug that is being considered for its potential to slow the progression of Alzheimer’s disease.
The Food and Drug Administration’s (FDA) Central and Peripheral Nervous System Drugs Advisory Committee met on Monday to discuss Eli Lilly’s donanemab.
Voting committee members were asked to vote on the question: “Do available data show that donanemab is effective in treating Alzheimer’s disease in the clinical trial population 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, Eli Lilly representatives noted a 29 percent slowdown in disease progression compared to a placebo group when 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) assessment, a 22% slowdown in disease progression was observed compared to the placebo group over the same time period.
All 11 voting members of the committee voted yes on the question of whether available data supported donanemab as an effective treatment for mild dementia. Several members said they voted yes because they felt there was an acceptable level of risk when compared to the data.
Some members, however, 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 tremendous step forward for people eligible for these medications. Progress in treatment is happening,” Joanne Pike, president and CEO of the Alzheimer’s Association, said in a statement.
“We now 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.”
Progressive consumer rights group Public Citizen spoke out against approving donanemab after the committee vote. The group argued in a statement that the study results, particularly the results using the iADRS scale, indicated that the drug was unlikely to be “clinically significant.”
“The advisory committee meeting was very disappointing. The essential question was not the specifics of donanemab’s potential prescribing information, but whether the drug should be approved in the first place,” Robert Steinbrook, director of Public Citizen’s Health Research Group, said in a statement after the vote.
The FDA has approved two other Alzheimer’s treatments in recent years, although one of them 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, there was a lack of evidence that the drug actually worked, and Biogen ended up giving 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 disease.
This story originally appeared on thehill.com read the full story
