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.
Eli Lilly will work with Roche to develop a blood test to detect the early stages of Alzheimer’s, the Swiss firm said in a statement on Wednesday.
The test, called the Elecsys Amyloid Plasma Panel, measures the levels of a particular protein in the blood that has been linked to the onset of Alzheimer’s.
While not intended as a standalone test—further confirmatory tests for Alzheimer’s would be needed—Roche said it speeds up the diagnostic process and helps direct people to the most appropriate resources.
As Alzheimer’s has a similar set of symptoms to other causes of dementia, a negative test is also useful and could help many people avoid the expensive and invasive tests used to confirm Alzheimer’s.
Roche Diagnostics chief executive Matt Sause said the firm is excited to be working with Lilly on “such an important area of unmet medical need.”
The test “has the potential to streamline a person’s journey to diagnosis” and, therefore, speed up access to future treatments, Sause added.
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.
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.
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)
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