Eli Lilly and Company is headquartered in Indianapolis, Indiana, United States, on Wednesday, May 3, 2023. Shares in Eli Lilly climbed in early U.S. trading after its experimental drug for Alzheimer’s disease slowed the progression of the disease in a final-stage trial, paving the way for the company to seek U.S. approval.
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Eli Lilly and Company The U.S. Food and Drug Administration said Friday push back Its deadline for a decision to approve the drugmaker’s experimental Alzheimer’s treatment, donanemab, was a surprising move.
Eli Lilly said the agency planned a last-minute meeting with outside advisers to further review the therapy’s safety and effectiveness in late-stage trials. The FDA has not yet revealed a date for that meeting, so approval could come after this month.
The FDA is expected to decide whether to approve the drug by the end of the first quarter. The deadline has been pushed back from last year’s expected approval.
Eli Lilly’s drug significantly slows progression of Alzheimer’s disease late stage trial. But this treatment, like similar drugs, has safety concerns related to brain swelling and bleeding.
The agency’s decision to hold an advisory meeting reflects the high stakes of developing a treatment for Alzheimer’s disease. The disease affects more than 6 million Americans and currently has no cure, leaving patients with few effective care options.
It’s another setback for Eli Lilly, which is battling rivals Biogen and Eisai. Their treatment, Leqembi, was approved last year and became the first drug shown to slow the progression of Alzheimer’s in patients with the early stages of the disease.
Both Leqembi and Eli Lilly’s drugs are monoclonal antibodies that target the accumulation of a protein in the brain called amyloid plaques, which are considered a hallmark of the disease.
Eli Lilly called the delay “unexpected,” but said it was confident in donanezumab’s “potential to provide very meaningful benefits to patients with early symptomatic Alzheimer’s disease.”
“We will work with the FDA and community stakeholders to conduct the demonstration and answer all questions,” Anne White, president of neuroscience at Lilly, said in a press release.
Eli Lilly noted that while it’s unusual for the FDA to hold advisory group meetings after a set action date, the agency has held similar meetings for two other amyloid-targeted therapies it previously approved.
The FDA often looks to advisory panels for advice on whether unapproved products are safe and effective.
The agency will generally follow the recommendations of its advisors, but is not required to do so. In 2021, the FDA approved Aduhelm, an early, ill-fated Alzheimer’s drug made by Biogen and Eisai, despite negative recommendations from the agency’s advisory panel.
The FDA will review an 18-month Phase 3 trial that followed more than 1,700 early-stage Alzheimer’s patients with confirmed amyloid plaques. The agency is interested in understanding safety results and how the trial’s “unique” design affects efficacy.
Eli Lilly’s research shows that once amyloid plaques are cleared from the brain, patients can stop taking the drug. Alzheimer’s drugs, including Leqembi, do not have designated stopping points for patients.
Eli Lilly’s drug showed positive results in that trial. Data showed that patients who received the drug experienced a 35% slower decline in memory, thinking skills and ability to carry out daily activities compared with those who did not receive treatment.
But according to the trial, 37% of people who took donanelumab developed brain swelling or bleeding, and three of them died. That compares with about 15% of people who received a placebo.
These side effects were also observed in Leqembi.
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