FDA Panel Endorses New Alzheimer’s Drug

by Denis Storey
June 11, 2024 at 12:24 PM UTC

An independent advisory panel =endorsed Eli Lilly’s new Alzheimer's drug, donanemab, paving the way for FDA approval by the end of the year.

Clinical relevance: An independent advisory panel unanimously endorsed Eli Lilly’s new Alzheimer’s drug, donanemab, likely leading to FDA approval by the end of the year.

  • FDA approval would make donanemab the second drug on the market to alter the course of Alzheimer’s disease.
  • The panel based its decision on positive Phase 3 trial results showing that donanemab significantly slowed clinical progression in early symptomatic patients.
  • While the committee recognized the drug’s benefits, they also called for more data on its performance in minority patients.

An independent advisory panel signed off on Eli Lilly’s new Alzheimer’s drug this week, paving the way for FDA approval. Analysts now expect the Food & Drug Administration to approve donanemab before the end of the year.

“We are pleased with the committee’s unanimous recognition of donanemab’s positive benefit-risk profile,” Eli Lilly Group Vice President of Neuroscience Research and Development Mark Mintun said after the announcement. “We look forward to bringing this treatment option to patients.”

FDA approval would make it the second drug on the market to alter the course of the disease. And it would mark only the third approval of this type of treatment. In short, the endorsement offers hope for the countrys 6 million Alzheimer’s patients.

“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs. Progress with treatment is happening,” Alzheimer’s Association president and CEO Joanne Pike, PhD, said. “Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety. This will lead to possibilities for combination therapies that address the complexity of the disease. A rich and robust life without the threat of memory loss, confusion or cognitive decline: this is what we envision.”

Overwhelming Support

In two separate votes, the Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that:

  • The available data backs up the manufacturer’s claims that it treats the disease effectively.
  • And the benefits outweigh the risks.

“There’s a huge unmet medical need here that hopefully can be addressed,” committee member Sarah Zenner-Dolan said in the June 10 meeting.

Dolan is a consultant at the Critical Path Institute, an Arizona independent nonprofit launched to help streamline the drug development – and approval – process.

The committee’s decision based its decision on several factors, but relied heavily on the donanemab TRAILBLAZER-ALZ 2 Phase 3 results, which appeared in the Journal of the American Medical Association in May 2023.

The committee also considered supporting studies and other data. However, multiple committee members added that they’d like to see more data on how the drug performs for minority patients.

An Effective New Alzheimer’s Treatment

The randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of donanemab, an “investigational amyloid plaque targeting therapy.” 

The researchers enrolled more than 1,700 participants who showed early symptomatic Alzheimer’s disease. Symptoms included mild cognitive impairment and mild dementia, with the confirmed presence of AD neuropathology. Participants finished their course of treatment with donanemab once they reached a prespecified level of amyloid plaque clearance.

The research showed that “donanemab significantly slowed clinical progression at 76 weeks in those with low/medium tau and in the combined low/medium and high tau pathology population.”

Donanemab works by helping the body purge amyloid plaque accumulation in the brain.

“We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial,” Lilly’s chief scientific and medical officer – and  Lilly Research Laboratories president – Daniel Skovronsky, M.D., Ph.D.,  said at the time in a press release. “This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.”

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