Eli Lilly headquarters in Indianapolis, Indiana, U.S., on Wednesday, May 3, 2023. Eli Lilly & Co. shares rose. In early US trading after its experimental Alzheimer's drug slowed the progression of the disease in a final-stage trial. This paves the way for the company to apply for US approval.
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Eli Lilly The Food and Drug Administration has postponed the deadline for a decision to approve experimental Alzheimer's treatment donanemab in a surprise move, the US drugmaker said on Friday.
Eli Lilly said the agency plans to call a last-minute meeting of its outside advisers to further review the safety and effectiveness of the treatment in the late-stage trial. The US Food and Drug Administration has not revealed the date of this meeting, so potential approval is likely to come after this month.
The Food and Drug Administration was expected to decide whether to give the drug the green light by the end of the first quarter. This deadline has already been postponed from approval expected last year.
Eli Lilly's drug significantly slowed the progression of Alzheimer's disease in a late-stage trial. But the treatment, along with similar medications, carries safety concerns related to brain swelling and bleeding.
The agency's decision to call an advisory meeting reflects the high stakes of developing treatments for Alzheimer's disease. This condition affects more than six million Americans, and currently has no cure, leaving patients with it with few effective care options.
It's another setback for Eli Lilly, who is racing to rival her Biogen And Jesus. Their treatment, Lekembe, received approval last year, becoming the first drug proven effective in slowing the progression of Alzheimer's disease in people in the early stages of the memory-stealing disease.
Both Leqembi and Eli Lilly's drugs are monoclonal antibodies that target the buildup of a protein in the brain called amyloid plaque, which is the hallmark of the disease.
Eli Lilly called the delay “unexpected,” but said it was confident in “donanemab's ability to provide very beneficial benefits to people with early symptoms of Alzheimer's disease,” according to a press release.
“We will work with the FDA and community stakeholders to make this presentation and answer all questions,” Anne White, head of neuroscience at Eli Lilly, said in a press release.
Eli Lilly noted that while it is unusual for the FDA to hold an advisory committee meeting after a specific action date, the agency has held similar meetings for two other amyloid plague treatments it has previously approved.
The FDA often turns to an advisory committee for advice on whether an unapproved product is safe and effective.
The agency typically follows the recommendations of its advisors, but is not required to do so. In 2021, the FDA approved an earlier ill-fated Alzheimer's drug called Aduhelm from Biogen and Eisai, despite a negative recommendation from the agency's advisory committee.
The FDA will examine the 18-month phase 3 trial, which followed more than 1,700 patients in the early stages of Alzheimer's disease who had a confirmed presence of amyloid plaque. The agency is interested in understanding the safety outcomes and how the “unique” design of the trial affected effectiveness.
The Eli Lilly study allowed patients to stop taking the drug once the amyloid plaques were removed from the brain. Alzheimer's medications, including Leqembi, do not have patient-specific breakpoints.
Eli Lilly's drug showed positive results in that trial. The data showed that patients who received the drug showed a 35% slower decline in memory, thinking, and their ability to perform daily activities compared to those who did not receive the treatment.
But 37% of people who took donanemab developed swelling or bleeding in the brain, including three who died, according to the trial. This compares to about 15% of people who received a placebo.
These side effects have also been observed in Lambi.
