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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)

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)

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)

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)

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)

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)