Roche is developing the tests in partnership with Indianapolis-based Eli Lilly and Co. Earlier this year, the U.S. Food and Drug Administration granted a breakthrough device designation to the product.
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Lilly called the lawsuit “baseless” and said PDL BioPharma “has no plausible claim to royalties” for donanemab, which is expected to be approved by the FDA this quarter.
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If U.S. regulators approve, the drug would be only the second Alzheimer’s treatment convincingly shown to delay the mind-robbing disease—after rival Leqembi. Both drugs pose a serious safety concern—brain swelling and bleeding.
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If approved, Donanemab has annual multi-billion-dollar sales potential. Lilly shares rose 6% in early-afternoon trading.
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The test—developed in collaboration with Eli Lilly and Co.—does not diagnose Alzheimer’s but is designed to rule out the presence of the disease’s pathology early on, or indicate further diagnostics are needed.
Eli Lilly and Co. this month launched a public awareness campaign called Brain Health Matters, which features actress Julianne Moore urging people to be proactive as they age to lower their risk of dementia, including Alzheimer’s disease.
Seven years of investigation by scientists at Harvard Medical School has revealed that the loss of the metal lithium plays a powerful role in Alzheimer’s disease, a finding that could lead to earlier detection, new treatments and a broader understanding of how the brain ages.
Indiana University School of Medicine researcher Jeff Dage’s years of research into biomarkers helped lead to a first-of-its-kind blood test to diagnose Alzheimer’s disease.
Syndeio Biosciences sees burgeoning potential to treat mental health and cognitive conditions, including Alzheimer’s and depression, with therapies that target the almost countless minuscule brain synapses that give people the ability to think and function.
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.
