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The FDA has paused its approval process for an experimental Alzheimer’s treatment to conduct a review of the drug with independent advisors, donanemab developer Eli Lilly and Company said in a statement on Friday.
The review could delay donanemab’s approval, which Eli Lilly executives had anticipated to come later this month.
“We were not expecting this,” Anne White, Lilly EVP and president of its neuroscience division, told the New York Times.
White added that the FDA’s call for a review so late in the approval process was unusual.
If approved, donanemab will join a similar FDA-approved drug, Leqembi, to treat the disease, which affects more than 6 million adults in the US. Both drugs are anti-amyloids, which mitigate memory loss by going after amyloids, or proteins that cluster in the brains of patients with Alzheimer’s. The leading theory points to the buildup of these proteins as the main cause for the disease.
According to the Eli Lilly statement, the FDA wants advisors to review the drug’s safety, along with its Phase 3 trial that “evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer’s disease.”
During Phase 3 clinical trials, donanemab showed some side effects, including brain swelling and microhemorrhages, which 31.4% of the 860 participants who took the therapy experienced.
Eli Lilly also said in its statement that two features of the trial drew the FDA’s attention: the short time some trial participants were on the drug and how the prominence of a protein called tau in participants correlated to the drug’s efficacy.
After amyloid forms in the brain, tau, which is connected to problems with thinking and memory, also develops, according to the National Institute on Aging. Donanemab trials revealed higher effectiveness in participants with lower tau levels. Compared to participants taking a placebo, those with “intermediate” tau levels experienced a 35% slower decline in performing normal tasks and thinking clearly compared to those on the placebo, per trial results. Participants with higher tau levels had a 22% slower decline compared to the placebo group.
One year into the trial, almost half of trial participants completed their donanemab regimen, which ended when amyloid levels fell below the threshold typically used to diagnose the disease. Even after they stopped taking the drug, a Phase 2 clinical trial found that amyloid levels could take nearly four years to reaccumulate.
Howard Fillit, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation said the FDA decision shouldn’t raise concern or undercut enthusiasm for donanemab.
“Today’s FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients,” he said in a statement. “The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi.”