FDA panel backs Eli Lilly's Alzheimer's drug

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.

Related Posts

  • Health
  • June 15, 2024
  • 4 views
  • 2 minutes Read
Honey bees can detect lung cancer in humans: study

(NewsNation) — Bad breath can say a lot about you. But soon it could help determine if you have lung cancer — or if a honeybee gets a whiff. Researchers…

  • Health
  • June 14, 2024
  • 4 views
  • 3 minutes Read
Sanders drops the subpoena after Novo Nordisk CEO agrees to testify

Sen. Bernie Sanders (I-Vt.) on Friday halted his search for a subpoena for a top pharmaceutical executive after the company's CEO agreed to testify before the Senate later this year.…

Leave a Reply

Your email address will not be published. Required fields are marked *

You Missed

New Jersey Senator Bob Menendez's strategy to blame his wife in a bribery trial could have pitfalls

  • June 15, 2024
New Jersey Senator Bob Menendez's strategy to blame his wife in a bribery trial could have pitfalls

FTC Chair Lina Khan on Startups, Scaling and 'Innovations in the Field of Possible Law Violations'

  • June 15, 2024
FTC Chair Lina Khan on Startups, Scaling and 'Innovations in the Field of Possible Law Violations'

Following a routine makes it easier to build wealth. Here's how

  • June 15, 2024
Following a routine makes it easier to build wealth.  Here's how

Investors are wondering whether technology can continue to lift the S&P 500 to new records this summer

  • June 15, 2024
Investors are wondering whether technology can continue to lift the S&P 500 to new records this summer

New research approach: investigating the mouthfeel of food with a microscope

  • June 15, 2024
New research approach: investigating the mouthfeel of food with a microscope

Salesforce (CRM) Q1 2025 Earnings Report

  • June 15, 2024
Salesforce (CRM) Q1 2025 Earnings Report

Quantum entanglement measures the rotation of the Earth

  • June 15, 2024
Quantum entanglement measures the rotation of the Earth

DOJ Destroys GOP Conspiracy That Controlled New York Trial

  • June 15, 2024
DOJ Destroys GOP Conspiracy That Controlled New York Trial

Nvidia's 'Nemotron-4 340B' model redefines synthetic data generation and competes with GPT-4

  • June 15, 2024
Nvidia's 'Nemotron-4 340B' model redefines synthetic data generation and competes with GPT-4

China needs bond market reforms to rein in rising debt, S&P Global says

  • June 15, 2024
China needs bond market reforms to rein in rising debt, S&P Global says

The tasty flavors of chocolate can pose a risk in other desserts

  • June 15, 2024
The tasty flavors of chocolate can pose a risk in other desserts