Stay up to date with notifications from The Independent

Notifications can be managed in browser preferences.

US delays decision over drug that could be used to cure Alzheimer’s

Donanemab is designed to clear from the brain a sticky protein called amyloid tied to Alzheimer’s

Reuters Correspondents
Julie Steenhuysen and Patrick Wingrove
Friday 08 March 2024 06:57 EST
Comments
A decison around Donanemab has been delayed
A decison around Donanemab has been delayed (Getty Images)

Your support helps us to tell the story

From reproductive rights to climate change to Big Tech, The Independent is on the ground when the story is developing. Whether it's investigating the financials of Elon Musk's pro-Trump PAC or producing our latest documentary, 'The A Word', which shines a light on the American women fighting for reproductive rights, we know how important it is to parse out the facts from the messaging.

At such a critical moment in US history, we need reporters on the ground. Your donation allows us to keep sending journalists to speak to both sides of the story.

The Independent is trusted by Americans across the entire political spectrum. And unlike many other quality news outlets, we choose not to lock Americans out of our reporting and analysis with paywalls. We believe quality journalism should be available to everyone, paid for by those who can afford it.

Your support makes all the difference.

The US has delayed a decision on whether to approve experimental treatment for patients with early Alzheimer’s disease.

The Food and Drug Administration will hold a meeting of outside experts to discuss the safety and efficacy of Eli Lilly’s drug.

This is the second regulatory delay for the drug, donanemab, after the company released clinical trial data last year that it says showed the treatment to be safe and effective.

Donanemab, given by infusion every two weeks, is designed to clear from the brain a sticky protein called amyloid tied to the fatal, memory-robbing disease.

Lilly said no date has been set yet for the advisory committee meeting to discuss the medicine, but it could be several months before it is held.

The Indianapolis-based drugmaker had first expected a decision by the end of last year, but in November said the FDA pushed that back until the first quarter of 2024 because the agency needed more time to review the approval application.

Lilly said there was no change to its 2024 financial forecast.

“This was definitely unexpected for us,” Anne White, president of Lilly Neuroscience, said in an interview. She noted that the news came very late in the review process and said the company had been ready to launch the drug.

White said the FDA wants the expert panel to discuss some of the unique aspects of the clinical trial used in its request for a traditional FDA approval, including issues around efficacy and safety.

In the trial, participants could stop treatment as soon as brain imaging showed that the drug had cleared the amyloid.

Donanemab was found to slow ‘clinical decline’ by up to 35% (PA)
Donanemab was found to slow ‘clinical decline’ by up to 35% (PA)

The drug is associated with swelling and bleeding in the brain and three people on the treatment in the company’s trial died.

The FDA also wants to review the implications of assessing patients based on levels of another Alzheimer’s-related protein called tau, which is closely linked with disease progression, White said.

“We don’t have a lot of details,” she said, noting that the agency has indicated a desire to move quickly. White said the agency will publish the meeting date in the Federal Register. They typically take place about two months after that publication.

“We certainly hope that after the advisory committee, they will make a decision quickly, and then we can make this medicine available to patients as we believe it should be,” White said.

The surprise delay follows the FDA’s decision a year ago not to grant the company an accelerated approval for the drug.

Donanemab would compete with a rival treatment, Leqembi, from Eisai and Biogen, which the FDA last year granted standard authorization and works in a similar manner.

More than 6 million Americans have Alzheimer’s, according to the Alzheimer’s Association.

Lilly said last year that donanemab was shown in a large clinical trial to slow progression of memory and thinking problems by 22% to 29% overall, depending on the rating scale used, which was roughly comparable to the 27% slowing seen with Leqembi.

In patients with low-to-medium levels of tau, the drug slowed disease progression by 35.1% compared with placebo, which was the main goal of the study.

Lilly’s late-stage study showed that brain swelling occurred in 24% of the donanemab treatment group. Brain bleeding occurred in 31% of the donanemab group and about 14% of the placebo group.

Join our commenting forum

Join thought-provoking conversations, follow other Independent readers and see their replies

Comments

Thank you for registering

Please refresh the page or navigate to another page on the site to be automatically logged inPlease refresh your browser to be logged in