FDA delays Alzheimer's drug for further review in surprise move

Source: Washington Post

March 8, 2024 at 8:52 a.m. EST


The U.S. Food and Drug Administration delayed regulatory action on an experimental Alzheimer’s drug that was widely expected to be approved this month, drugmaker Eli Lilly said Friday, citing a need for more review to establish its safety and effectiveness.

The FDA plans to hold an advisory committee meeting to further scrutinize donanemab, one of few treatments developed for Alzheimer’s disease, a debilitating and incurable affliction that affects some 6 million Americans.

The agency’s action reflects a cautious approach, experts said. The FDA drew criticism in 2021 after approving a different Alzheimer’s drug that showed conflicting results about its effectiveness. And it comes as public pressure mounts for therapies to fend off the memory-robbing disease, after decades of research have only produced a handful of drugs that aim to slow Alzheimer’s progression or treat its symptoms.

The call for additional scrutiny surprised Eli Lilly executives, who said it is unusual for such a review to occur after the FDA has given an anticipated date to make a decision on approval.

Read more: https://www.washingtonpost.com/business/2024/03/08/eli-lilly-alzheimers-donanemab-fda/