Trial Data: Eli Lilly Treatment Modestly Slows Alzheimer’s Progression
Clinical trial data released by Eli Lilly Wednesday suggests that its antibody treatment donanemab may work better than an-already approved rival drug at slowing cognitive and functional decline in Alzheimer's patients. But this therapy also has risks of deaths and serious brain side effects.
Reuters:
Lilly Drug Slows Alzheimer's By 35%, Bolstering Treatment Approach
An experimental Alzheimer's drug developed by Eli Lilly and Co slowed cognitive decline by 35% in a late-stage trial, the company said on Wednesday, providing what experts say is the strongest evidence yet that removing sticky amyloid plaques from the brain benefits patients with the fatal disease. Lilly's drug, donanemab, met all goals of the trial, the company said. It slowed progression of Alzheimer's by 35% compared to a placebo in 1,182 people with early-stage disease whose brains had deposits of two key Alzheimer's proteins, beta amyloid as well as intermediate levels of tau, a protein linked with disease progression and brain cell death. (Steenhuysen and Beasley, 5/3)
Science:
‘It’s Not A Miracle Drug’: Eli Lilly’s Antibody Slows Alzheimer’s Disease But Safety Issues Linger
But Eli Lilly’s preliminary donanemab results also reveal a sobering risk of brain swelling and hemorrhaging, side effects that the company disclosed may be linked to two—perhaps three—deaths in the clinical trial and that echo hazards seen with lecanemab, which is being marketed by Eisai and Biogen. With the U.S. Food and Drug Administration considering full approval for lecanemab next month and Eli Lilly vowing to quickly submit donanemab to the agency for review, many physicians, Alzheimer’s patients, and their caregivers may soon face difficult conversations about whether to risk immediate harm to take these therapies, the first to be clinically proven to somewhat thwart a slow but inexorable destroyer of the brain. (Travis, 5/4)
Stat:
For Lilly Scientist, Alzheimer’s Results Cap A 25-Year Scientific Quest
If you flip to the 1,031st page of the May 1998 edition of the Journal of Cell Biology, you’ll find the first scientific byline for Daniel Skovronsky, then a young trainee at the University of Pennsylvania, on an article describing how beta-amyloid, a vexing molecule thought to play a role in Alzheimer’s disease, was more complicated than the field understood. “I’ve been pursuing the same enemy for 25 years,” Skovronsky, now head of research at Eli Lilly, said at the STAT Breakthrough Summit in San Francisco on Wednesday. (Garde, 5/3)
On one potential impact of the drug —
Stat:
New Eli Lilly Alzheimer’s Data Poses Medicare Coverage Conundrum
Eli Lilly’s latest anti-amyloid Alzheimer’s treatment seems to slow the disease, the company announced this week — news that adds even more pressure on Medicare’s unprecedented restrictions on coverage. Medicare has so far held firm on its plans to require patient registries for the entire class of anti-amyloid Alzheimer’s drugs, even after they are fully approved. Pharmaceutical groups and patient advocates are increasingly fighting that approach. (Cohrs, 5/4)
Also —
Stat:
Do Viruses Cause Alzheimer’s Disease?
On a day when pharma giant Eli Lilly announced positive results from a clinical trial of an Alzheimer’s drug that clears knotty clumps of protein from the brain, researchers at STAT’s Breakthrough Summit discussed another promising though preliminary approach to treating the disease: targeting viruses and bacteria. (Wosen, 5/3)
