Eli Lilly Alzheimer’s drug FDA approval delayed

Eli Lilly said Friday that the Food and Drug Administration has pushed back its approval decision deadline for the drugmaker’s experimental Alzheimer’s treatment donanemab in a surprise move.

The agency plans to call a last-minute meeting of its outside advisors to further review the treatment’s safety and efficacy in a late-stage trial, Eli Lilly said. The FDA has not disclosed the date of that meeting, so a potential approval would likely come after this month.

The FDA was expected to decide whether to greenlight the medicine by the end of the first quarter. That deadline was already delayed from an expected approval last year. 

Eli Lilly’s drug significantly slowed Alzheimer’s progression in a late-stage trial. But the treatment, along with similar drugs, carries safety concerns related to brain swelling and bleeding.

The agency’s decision to call for an advisory meeting reflects the high stakes of developing treatments for Alzheimer’s. The condition affects more than six million Americans and currently has no cure, leaving patients who have it with few effective care options. 

It’s another setback for Eli Lilly, which is racing to compete with Biogen and Eisai. Their treatment Leqembi won approval last year, becoming the first medicine proven to slow the progression of Alzheimer’s in people at the early stages of the memory-robbing disease. 

Both Leqembi and Eli Lilly’s drug are monoclonal antibodies that target buildups of a protein in the brain called amyloid plaque, which is considered a hallmark of the disease.

Eli Lilly called the delay “unexpected,” but said it is confident in donanemab’s “potential to offer very meaningful benefits to…