The European Medicines Agency committee said the benefits of the new drug, Kisunla, did not outweigh the risks, and it recommended refusing marketing authorization for it.
Two new drugs—including one from Indianapolis-based Eli Lilly—and better detection methods offer promise for people dealing with the disease.
Victoza yielded mixed results in a mid-stage study of Alzheimer’s disease, failing to meet its primary goal while showing hints that larger trials of similar drugs may be successful.
Researchers reported Sunday that new blood tests were 91% accurate in detecting Alzheimer’s disease, far more accurate than a diagnosis from primary care doctors and specialists.
Eli Lilly’s drug—Kisunla, the brand name for donanemab—is one of the few treatments developed for Alzheimer’s that modifies the underlying disease and will join just one other drug, Leqembi, on the commercial market.
Lilly officials have said they are “incredibly confident” in the drug’s potential and the fact that it “offers very meaningful benefits to people with early symptomatic Alzheimer’s disease.”
The U.S. Food and Drug Administration is convening a panel of independent experts on June 10 to discuss donanemab’s safety and effectiveness, including the results in patients in a clinical trial.
Roche and Lilly said they believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.
The call for additional scrutiny surprised Lilly executives, who noted that it is unusual for such a review to occur after the FDA has given an anticipated date to make a decision on approval. An OK for the drug had been expected this month.
A number of studies have found that people receiving vaccinations for flu and several other infectious diseases appear less likely than the unvaccinated to develop dementia, although scientists aren’t sure why.
More than 110,000 Hoosiers suffer from Alzheimer’s disease, which robs people of their memories and abilities to do daily tasks, and is the nation’s sixth-leading cause of death.
Groups such as the Alzheimer’s Association have pushed Medicare to cover the new Alzheimer’s drugs—including those cleared on an expedited basis—saying that the FDA should be the final arbiter of safety and efficacy of drugs.
Eli Lilly said the study concludes its clinical development of solanezumab, apparently shutting the door on one of the most closely watched experimental drugs over the past decade.
Five of the top 10 research studies that received the most NIH funding at the medical school were for Alzheimer’s disease or brain aging, one of the school’s top priorities.
Donanemab’s ability to rapidly remove amyloid beta from patients’ brains prevented the required number of patients from receiving the drug for a full 12 months, Lilly said, resulting in the FDA rejection.
It’s the first drug that’s been convincingly shown to slow the decline in memory and thinking that define the disease. But the medication comes with downsides, including potentially serious side effects and the need for frequent drug infusions.
The Food and Drug Administration’s contentious approval of Alzheimer’s drug Aduhelm took another hit Thursday as congressional investigators questioned the integrity of the process.
An experimental Alzheimer’s drug modestly slowed the brain disease’s inevitable worsening, researchers reported Tuesday—but it remains unclear whether that will have an impact on people’s lives.
Gantenerumab’s demise is a boost for Indianapolis-based Eli Lilly and Biogen, which are also developing treatments for Alzheimer’s, said Tim Anderson, an analyst at Wolfe Research. Lilly shares were up 1.8% at midday.
The IU School of Medicine announced won a five-year, $48.8 million grant from the National Institute on Aging, a division of the National Institutes of Health, to create in mice genetic mutations similar to those found in people with late-onset Alzheimer’s.
