Home Medizin FDA verzögert Entscheidung zum Alzheimer-Hoffnungsträger Donanemab

FDA verzögert Entscheidung zum Alzheimer-Hoffnungsträger Donanemab

von NFI Redaktion

The US Food and Drug Administration (FDA) has postponed its decision expected for this month on the approval of Donanemab for the treatment of Alzheimer’s disease (AD).

Instead, the FDA will convene a meeting of external experts to discuss the Phase 3 TRAILBLAZER-ALZ 2 study, which evaluated the effectiveness and safety of Donanemab in early symptomatic AD.

In a statement, Eli Lilly said the FDA has informed the company that it „wants to better understand issues related to the evaluation of the safety and efficacy of Donanemab, including safety outcomes in patients treated with Donanemab and the impact of the unique study design on efficacy. The TRAILBLAZER-ALZ 2 study, including its time-limited dosing regimen which allowed patients to complete treatment based on amyloid plaque assessment, and the inclusion of participants based on tau levels.“

„It was unexpected to learn that the FDA will convene an advisory committee at this point in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and contextualize the strong efficacy of Donanemab within the safety profile,“ said Anne White, Executive Vice President of Eli Lilly and Company and President of Lilly Neuroscience, in a statement.

The date for the FDA advisory committee meeting to review Donanemab data has not been set, meaning a decision on the drug will extend 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 compared to placebo.

The main risk associated with Donanemab (as with other anti-amyloid agents) are amyloid-related imaging abnormalities (ARIAs), which occurred in 36.8% of the treatment group compared to 14.9% of the placebo group, and in 40.6% of patients who were homozygous for APOE e4 and received the drug. Microbleeds occurred in 26.8% in the Donanemab group compared to 12.5% in the placebo group.

Most cases of ARIAs were mild to moderate and resolved or stabilized with appropriate treatment. However, it was noted that three deaths in participants who developed severe ARIAs or brain bleeds and swelling were drug-related.

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 Scientific Director of the Alzheimer’s Drug Discovery Foundation, said the FDA’s decision to convene an advisory session on Donanemab is „not a setback, but rather a step forward in the drug approval process with the regulatory agency.“ The agency is conducting its due diligence review before distributing the drug to patients.

„The TRAILBLAZER-ALZ 2 study symbolizes a new era in Alzheimer’s research, where we can now conduct innovative studies that definitively tell us whether a drug is effective. As the first class of Alzheimer’s drugs hits the market – with promise.“ „There are many more novel therapies that will follow – the field is working together to pave the way for future drug approvals,“ Fillit said.

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