Even as some drugmakers, including Indianapolis-based Eli Lilly and Co., are pushing to get experimental drugs approved, federal regulators are still dealing with a huge blowback over the controversial way they reviewed a new Alzheimer’s drug by rival Biogen.
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Shares of Biogen competitors soared after aducanumab became the first drug cleared by the U.S. Food and Drug Administration to slow the course of the mind-wasting disease that afflicts 6 million Americans.
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Eli Lilly and Co. on Saturday morning presented highly anticipated details from a mid-stage study showing that its experimental drug slowed Alzheimer’s disease progression over about 18 months.
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Lilly has spent three decades and more than $3 billion trying to find a way to treat Alzheimer’s disease. Its latest drug, donanemab, finally shows real promise.
Read MoreThe narrower label means the drug might be offered to 1 million or 2 million Alzheimer’s patients, rather than the more than 6 million people with Alzheimer’s in the United States.
The role of the sticky substance in the brain has long divided researchers and is at the forefront again amid the FDA’s recent clearance of the first drug to treat the disease in almost two decades.
Eli Lilly and Co. shares jumped more than 9% Thursday morning after it received “breakthrough therapy” designation for donanemab from the U.S. Food and Drug Administration, putting the drug on a path that could expedite its development.
Critics have blasted the approval of Aduhelm, saying the drug—with a list price of $56,000 a year per patient—offers false hope while threatening Medicare’s financial health and patients’ pocketbooks.
Separately, Dr. Aaron Kesselheim of Harvard University became the third member of an FDA advisory panel that opposed the drug to step down over the decision to approve it.
The decision, which could affect millions of older Americans and their families, also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
Indianapolis-based Eli Lilly and Co. is set to report results from a trial of its experimental Alzheimer’s medicine on Saturday in a move that could boost shares of the year’s already best-performing big drugmaker.
Preliminary reports from the Centers for Disease Control and Prevention indicate that there were at least 42,000 more deaths from Alzheimer’s and other dementias in 2020 compared with the average of the five years prior.
The experimental drug, donanemab, could be a huge breakthrough for Lilly, which has spent billions of dollars over 30 years researching treatments for Alzheimer’s disease, only to see them fall short in clinical trials.
Independent experts are leery because key test results have not been published and the test has not been approved by the U.S. Food and Drug Administration—it’s being sold under more general rules for commercial labs.
The Biogen drug, known as aducanumab, does not cure or reverse Alzheimer’s, but it might modestly slow the rate of decline.
An experimental blood test from Indianapolis-based Eli Lilly and Co. was highly accurate at distinguishing people with Alzheimer’s disease from those without it in several studies, boosting hopes that there soon may be a simple way to help diagnose the condition.
Digging through old data to salvage a seemingly failed Alzheimer’s drug paid off big time for Biogen Inc., but at least one of its rivals has no plans to follow suit.
Seven months after clinical trials for a promising Alzheimer’s drug were halted and the treatment was declared a failure, a new analysis suggests it was actually effective, and the company that makes it plans to move forward in securing federal approval.
The grant, to be paid over five years, will help the IU School of Medicine launch a drug discovery center as part of a strategic partnership with the Purdue Institute for Drug Discovery at Purdue University.
The IU School of Medicine said the grant, its largest-ever National Institutes of Health award, will fund a five-year study of a form of Alzheimer’s disease that affects young people.
While the ultimate outcome remains far from certain, the study is a bright spot—if a tenuous one—in the search for a treatment for Alzheimer’s, where more than 100 experimental drugs have failed.
An independent data-monitoring committee found that the medicine, lanabecestat, was unlikely to meet the goals of the studies, one for early Alzheimer’s and the other for mild dementia related to the disease.
The Food and Drug Administration proposal will create new opportunities for drugmakers after repeated failures from companies including Indianapolis-based Eli Lilly and Co.
The study will focus on early-onset Alzheimer’s disease, which are about 5 percent of patients.
