FDA postpones approval for Eli Lilly’s Alzheimer’s drug

(NBC, KYMA/KECY) - The Food and Drug Administration (FDA) has decided to postpone their approval decision deadline for Eli Lilly's experimental Alzheimer's drug.

A source familiar with the agency's planning said the FDA was initially set to decide on the drug "donamemab's" approval by early next week, but in an unexpected move, the FDA told Lilly it wanted to "further understand topics" related to the drug's safety and effectiveness before making a decision, as well as get input from its independent advisory committee.

However, a date has not been set for when that committee will meet.

Lilly first applied to the FDA for approval in July 2023 after clinical trial results showed the "donamemab" slowed the progression of Alzheimer's by 29% after 18 months, compared to a placebo.

If the drug had been cleared for use, this would make the third approval in the U.S. of the new class of alzheimer's drugs aimed at slowing the progression of the disease.

According to the Alzheimer's Association, 6.7 million adults age 65 and older in the U.S. have the disease.