FDA delays action on Lilly's Alzheimer's drug
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The Food and Drug Administration is asking outside advisers to review the safety and efficacy of an experimental Alzheimer's drug from Eli Lilly that was expected to be approved in the first quarter of this year.
Why it matters: Donanemab was shown to be effective in slowing the disease's progression by about a third, and would be the second drug of its kind to receive full FDA approval and corresponding Medicare coverage.
- But there had been lingering questions about whether its usefulness outweighs safety risks after some patients enrolled in a clinical trial experienced brain swelling and bleeding.
Driving the news: Lilly said on Friday that the FDA expects to convene an advisory committee meeting "related to evaluating the safety and efficacy of donanemab," and the design of a clinical trial used to back its application.
- Donanemab targets proteins known as amyloid plaques that are believed to contribute to the development of Alzheimer's.
- "It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab's strong efficacy in the context of safety," Anne White, Lilly executive vice president, said in a statement.
Between the lines: Experimental drugs like donanemab were providing more hope to the more than 6 million people living with Alzheimer's in the U.S.
- An 18-month trial of more than 1,700 participants aged 60 to 85 years found it to be 35% effective at slowing the rate of the disease — the equivalent of four and a-half to seven and a-half months of delayed cognitive decline.
- It was found to be 60% effective in early stage patients.
What they're saying: The Alzheimer's Drug Discovery Foundation said in a statement Friday that the donanemab trial used a "goldilocks strategy" that used biomarkers to identify patients who were most likely to benefit from treatment.
- "Today's FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients," said Howard Fillit, the foundation's co-founder and chief science officer.
Catch up quick: The FDA in July approved a rival drug, Eisai and Biogen's Leqembi, after it was shown to also have modest success delaying cognitive decline by 27% over 18 months.
- Budget experts say the new wave of drugs that can delay the memory-robbing disease have the potential to quickly drive up health insurance costs and jeopardize sustainable access to high-value care.
What's next: The date of the advisory committee meeting hasn't been set, meaning the timing of any action on donanemab will be pushed beyond the first quarter, Lilly said.
