Alzheimer’s Blood Test That Could Help Diagnose Disease Earlier Is Being Developed By Eli Lilly And Roche

Topline

Swiss pharma giant Roche on Wednesday announced plans to jointly develop a blood test for Alzheimer’s disease with American heavyweight Eli Lilly, eying swift U.S. approval as companies race to create and sell the very first drugs aimed at slowing the progressive cognitive decline brought on by the incurable illness.

Key Facts

News Peg

There is no cure for Alzheimer’s and, until recently, there was no treatment to slow the disease’s progression. The FDA controversially approved Biogen’s aducanumab, sold as Aduhelm, in 2021. The clinical data supporting the decision has been heavily criticized, as was the FDA’s adherence to protocol in approving it. The agency greenlit lecanemab, sold as Leqembi and produced by Biogen and Japan’s Eisai, on an expedited basis in January, though access is limited. The agency is expected to make a complete decision on the drug in July. Both treatments are monoclonal antibodies that target a type of protein that builds up in the brain of people with Alzheimer’s. As they are aimed at slowing progression, early detection can be key and help preserve as much of the brain’s functioning as possible. While certainly medical breakthroughs, they are eye-wateringly expensive, require frequent intravenous administration and, at best, appear to only modestly slow mental decline. Future Alzheimer’s drugs with similar targets—Lilly is in the final stages of clinical trials for one—are likely to also benefit from earlier intervention.

What To Watch For

Roche and Lilly are eying U.S. regulatory approval for the test. They are aiming to file clinical trial data with U.S. regulators in 2025, Bruce Jordan, leader of personalized healthcare solutions at Roche Diagnostics told Reuters. Between now and then, Roche said it will recruit several hundred volunteers with early signs of dementia to trial the treatment and gather data.

Key Background

Alzheimer’s Disease is a progressive brain disorder marked by the slow erosion of cognitive abilities and memory. It is the most common type of dementia, a broad category used to describe conditions linked to cognitive decline, and is primarily, though not exclusively, a condition affecting older adults. There are as many as 5.8 million Americans living with Alzheimer’s, the CDC estimates, and it is the sixth leading cause of death among U.S. adults. That figure is projected to grow to 14 million people by 2060 and the costs associated with the disease are expected to reach up to $500 billion annually by 2040 in the U.S. alone. Though strides have been made in recent years, there is a great deal we do not know about Alzheimer’s. Scientists are still not settled on what causes it—a matter of heated debate—or why it appears more often as we grow older.

Further Reading

Could Alzheimer’s be caused by an infection? (The Observer)

FDA declines to grant accelerated approval for Eli Lilly’s experimental Alzheimer’s treatment (CNN)