The US Food and Drug Administration (FDA) has put off a decision expected this month on whether to approve donanemab for Alzheimer’s disease (AD).
Instead, the FDA will convene a meeting of outside experts to discuss the phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic AD.
In a statement, Eli Lilly said the FDA informed the company that it wants to “further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limited-duration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels.”
“It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab’s strong efficacy in the context of safety,” Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in a statement.
The date of the FDA advisory committee meeting to review the donanemab data has yet to be set, which means a decision on the drug will go beyond the first quarter of 2024, when the decision was expected.
The TRAILBLAZER-ALZ 2 study showed that donanemab significantly slowed cognitive and functional decline in patients with early, symptomatic AD in comparison with placebo.
The key risk associated with donanemab (as with other antiamyloid agents) is amyloid-related imaging abnormalities (ARIAs) — which occurred in 36.8% of the treatment group vs 14.9% of the placebo group, and in 40.6% of patients who were homozygous for APOE e4 and received the drug. Microhemorrhage occurred in 26.8% in the donanemab group vs 12.5% in the placebo group.
Most ARIA cases were mild to moderate and resolved or stabilized with appropriate management. However, three deaths were determined to be drug-related among participants who developed serious ARIAs or brain bleeding and swelling.
As previously reported by Medscape Medical News, the TRAILBLAZER-ALZ 2 results were presented at the Alzheimer’s Association International Conference 2023 and simultaneously published online on July 17 in JAMA.
In a statement sent to Medscape Medical News, Howard Fillit, MD, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said the FDA decision to convene an advisory meeting on donanemab 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.”
“The TRAILBLAZER-ALZ 2 trial is emblematic of a new era of Alzheimer’s research where we are now able to conduct innovative trials that can definitively tell us whether a drug is effective. As the first class of Alzheimer’s drugs come to market—with the promise of more novel therapies to follow—the field is working together to build the path forward for future drug approvals,” Fillit said.
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