FDA Refuses Accelerated Approval Request For Eli Lilly Alzheimer’s Drug
Eli Lilly has been declined an accelerated approval process for its Alzheimer's drug donanemab, a treatment for people in the early stage of the disease. The company says, however, that a Phase 3 study of the drug is on track. The FDA is said to be seeking more data.
Stat:
FDA Rejects Lilly’s Bid For Accelerated Approval For Alzheimer’s Drug
Eli Lilly said Thursday that U.S. regulators had rejected its application seeking accelerated approval for donanemab, a treatment for people with early stage Alzheimer’s disease. Despite the setback, Lilly said that the planned readout from an ongoing, Phase 3 study of donanemab remains on track for the middle of the year, and if positive, will form the basis of an application for full approval “shortly thereafter.” (Feuerstein, 1/19)
The Washington Post:
FDA Declines To Give Accelerated Approval To Eli Lilly’s Alzheimer’s Drug, Firm Says
Eli Lilly said it received a “complete response letter” from the FDA — a notice that outlines the agency’s reasons for declining to approve the drug application in its current form. Lilly officials said the agency wants to see safety data on at least 100 patients in clinical trials who have taken the drug continuously for at least 12 months. (McGinley, 1/19)
The Wall Street Journal:
FDA Seeks More Data On Lilly’s Alzheimer’s Drug Candidate
Lilly said it would work with the FDA to evaluate the fastest pathway to get the drug to market. The company is running a late-stage study testing donanemab in more subjects, with results expected during the second quarter. The FDA indicated it would likely need data from this larger study to make a decision, Lilly said. (Loftus, 1/19)
In other news about Alzheimer's disease —
National Institute On Aging:
Could A Viral Illness Increase Chances Of Developing Alzheimer’s Or Other Neurodegenerative Disease?
Some viral illnesses may increase a person’s chances of later developing Alzheimer’s disease or another neurodegenerative disorder. Though a causal link cannot be confirmed, an NIH study in which researchers mined the medical records of hundreds of thousands of people in Finland and the United Kingdom found significant associations. ... The strongest risk association was between viral encephalitis — an inflammation of the brain caused by a virus — and Alzheimer’s disease. (1/19)
Scientific American:
An Old TB Vaccine Might Help Stave Off Diabetes, Cancer Alzheimer's, And More
Beyond protecting against various infections, researchers are starting to find that the BCG vaccine can also modulate the risk of other diseases in which the immune system goes awry, including type 1 diabetes, cancer, multiple sclerosis and Alzheimer’s disease. Claims about such broad-ranging effects have been controversial but have grown less so in recent years. Open questions still linger, however, as to which patient groups, and for which conditions, the nonspecific effects of BCG might produce a meaningful clinical benefit. (Callier, 1/19)
NBC News:
3 Unanswered Questions About The Newly Approved Alzheimer's Drug Leqembi
A newly approved Alzheimer's drug will be available to patients in the coming days, according to its maker, the Japanese pharmaceutical company Eisai. The drug, called Leqembi, was shown in clinical trials to slow the progression of Alzheimer’s disease in people with mild cognitive impairment or early-stage illness. It is not a cure. (Lovelace Jr., 1/18)
