Eli Lilly headquarters in Indianapolis, Indiana, U.S., on Wednesday, May 3, 2023. Shares of Eli Lilly & Co. rose in early U.S. trading after its experimental Alzheimer's drug slowed disease progression in a late-stage trial. paving the way for the company to apply for US approval.
AJ Neck | Bloomberg | fake images
Eli Lilly The Food and Drug Administration said Friday that it has delayed the deadline for approval of the drugmaker's experimental Alzheimer's treatment donanemab in a surprise move.
The agency plans to convene a last-minute meeting of its outside advisers to further review the safety and effectiveness of the treatment in a late-stage trial, Eli Lilly added. The FDA has not revealed the date of that meeting, so a possible approval would likely come after this month.
The FDA was expected to decide whether to give the drug the green light by the end of the first quarter. That deadline has already been pushed back from an approval expected last year.
The agency's decision to convene an advisory meeting reflects how much is at stake in developing treatments for Alzheimer's. The condition affects more than six million Americans and currently has no cure, leaving patients with the condition with few options for effective care.
It's another setback for Eli Lilly, which is racing to compete biogen and Eisai. Its Leqembi treatment gained approval last year, becoming the first drug shown to slow the progression of Alzheimer's in people in the early stages of the memory-robbing disease.
Eli Lilly called the delay “unexpected” but said it is confident in donanemab's “potential to deliver very significant benefits to people with early symptomatic Alzheimer's disease,” according to a statement.
“We will work with the FDA and community stakeholders to make that presentation and answer all questions,” Anne White, president of neuroscience at Eli Lilly, said in a statement.
