Eli Lilly headquarters in Indianapolis, Indiana, US, on Wednesday, May 3, 2023. Eli Lilly & Co.’s shares climbed in early US trading after its experimental drug for Alzheimer’s slowed the progress of the disease in a final-stage trial, paving the way in which for the corporate to use for US approval.
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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 possible approval would likely come after this month.
The FDA was expected to come to a decision whether to greenlight the medication by the tip of the primary quarter. That deadline was already delayed from an expected approval last yr.
Eli Lilly’s drug significantly slowed Alzheimer’s progression in a late-stage trial. However the treatment, together 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 greater than 6 million Americans and currently has no cure, leaving patients who’ve it with few effective care options.
It’s one other setback for Eli Lilly, which is racing to compete with Biogen and Eisai. Their treatment Leqembi won approval last yr, becoming the primary medicine proven to slow the progression of Alzheimer’s in people on the early stages of the memory-robbing disease.
Each Leqembi’s and Eli Lilly’s drug are monoclonal antibodies that concentrate on buildups of a protein within the brain called amyloid plaque, which is taken into account a trademark of the disease.
Eli Lilly called the delay “unexpected,” but said it’s confident in donanemab’s “potential to supply very meaningful advantages to individuals with early symptomatic Alzheimer’s disease,” in line with a release.
“We are going to work with the FDA and the stakeholders in the neighborhood to make that presentation and answer all questions,” said Anne White, president of neuroscience at Eli Lilly, in a release.
Eli Lilly noted that while it’s unusual for the FDA to carry an advisory panel meeting after a set motion date, the agency has convened similar meetings for 2 other amyloid plague-targeting therapies that it previously approved.
The FDA often turns to an advisory panel for advice on whether an unapproved product is protected and effective.
The agency often follows the recommendations of its advisors, but is not required to. In 2021, the FDA approved an earlier, ill-fated Alzheimer’s drug called Aduhelm from Biogen and Eisai, despite a negative suggestion from the agency’s advisory panel.
The FDA will examine an 18-month phase 3 trial, which followed greater than 1,700 patients within the early stages of Alzheimer’s who had a confirmed presence of amyloid plaque. The agency is serious about understanding the protection results and the way the trial’s “unique” design affected efficacy.
Eli Lilly’s study allowed patients to stop taking the drug once the amyloid plaques were shown to be cleared from the brain. Alzheimer’s drugs, including Leqembi, haven’t got designated stopping points for patients.
Eli Lilly’s drug showed positive ends in that trial. Patients who received the drug demonstrated a 35% slower decline in memory, pondering and their ability to perform every day activities compared with those that didn’t receive the treatment, data shows.
But 37% of people that took donanemab had brain swelling or bleeding, including three who died, in line with the trial. That compares with around 15% of people that received a placebo.
Those uncomfortable side effects have also been observed in Leqembi.