Decision on Eli Lilly’s Alzheimer’s drug delayed by U.S. FDA

The U.S. Food and Drug Administration has delayed its decision on Eli Lilly's LLY.N experimental treatment for early Alzheimer's disease.

The U.S. Food and Drug Administration has delayed its decision on Eli Lilly’s LLY.N experimental treatment for early Alzheimer’s disease and will hold a meeting of outside experts to discuss its safety and efficacy, the company said.

The FDA’s decision came as a surprise to company officials and many Alzheimer’s experts, who had expected a full approval for Lilly’s drug donanemab this month based on clinical trial data last year that showed the treatment was safe and effective.

No date has been set for the advisory committee meeting, but it could be several months before it is held. Eli Lilly shares were down three per cent, while shares of Biogen BIIB.O, which sells a rival drug, were up more than two per cent.

This marks the second delay for the eagerly anticipated treatment by the FDA after it declined to grant accelerated approval for the medicine a year ago.

Drugs like donanemab, which slow disease progression in early-stage patients, represent a new era in the treatment of Alzheimer’s, after three decades of failed attempts to fight the fatal disease that affects more than six million Americans, according to the Alzheimer’s Association.

“This was definitely unexpected,” Anne White, president of Lilly Neuroscience, said in an interview, adding that the news came very late in the review process and the company had been ready to launch the drug.

White said the FDA wants the expert panel to discuss some of the unique aspects of the clinical trial used in its request for a traditional FDA approval, including issues around efficacy and safety.

The FDA had conducted advisory committee meetings before approving Eisai 4523.T and Biogen’s Leqembi, which received standard authorization last year and works in a similar manner. The agency declined to comment on its decision.