Donanemab is an experimental Alzheimer's drug designed to attack a sticky substance in the brain known as amyloid beta, which has been linked to Alzheimer's disease. Clinical trials have shown that donanemab slows cognitive decline of people in the early stages of the disease.
The FDA plans to hold an advisory panel hearing on how safe and effective donanemab is.
The U.S. Food and Drug Administration (FDA) has delayed regulatory action on an experimental Alzheimer's drug called donanemab, which was widely expected to be approved this month. The FDA plans to hold a hearing of external advisers to explore how safe the therapy is and how well it works.
Donanemab is designed to attack a sticky substance in the brain known as amyloid beta, which has been linked to Alzheimer's disease. Clinical trials have shown that donanemab slows cognitive decline of people in the early stages of the disease.
The FDA's decision reflects a cautious approach and comes just weeks before it was expected to rule on approving the drug. The agency drew criticism in 2021 after approving a different Alzheimer's drug that showed conflicting results about its effectiveness. And it comes as public pressure mounts for therapies to fend off the debilitating and incurable affliction that affects some 6 million Americans.
The FDA has informed Eli Lilly, the company behind donanemab, of its plans to hold an advisory panel hearing. The meeting date hasn't yet been set.
The FDA delayed regulatory action on an experimental Alzheimer's drug called donanemab.
Donanemab is designed to attack a sticky substance in the brain known as amyloid beta, which has been linked to Alzheimer's disease.
Clinical trials have shown that donanemab slows cognitive decline of people in the early stages of the disease.
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The article contains an example of a false dilemma fallacy. The author presents the idea that donanemab is either safe and effective or it isn't, when in reality there are many factors to consider such as side effects and long-term benefits. Additionally, the use of inflammatory rhetoric by experts quoted in the article could be seen as an appeal to authority fallacy.
The FDA plans to hold an advisory committee meeting to further scrutinize donanemab
Eli Lilly executives were surprised by the call for additional review
Donanemab is designed to attack a sticky substance in the brain known as amyloid beta, which has been linked to Alzheimer's
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The article discusses the FDA's decision to delay Eli Lilly's Alzheimer's drug Donanemab for further review. The authors have a financial stake in Eli Lilly as they are employed by the company and may be biased towards reporting on positive developments related to their employer.
The article mentions that Daniel Gilbert is an employee of Eli Lilly, which could indicate a potential conflict of interest.
The US Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial.
Donanemab is designed to attack a sticky substance in the brain known as amyloid beta, which has been linked to Alzheimer's disease.
Accuracy
The FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease.
The FDA has informed Lilly 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.
Compared to participants in similar trials of other amyloid plaque-targeting therapies, the TRAILBLAZER-ALZ 2 participants were more progressed in their disease.
Deception
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The article is deceptive in several ways. Firstly, it states that the FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab. However, this statement implies that there are concerns about the safety or efficacy of donanemab when no such concerns have been stated by the FDA. Secondly, it states that all groups of trial participants benefited from treatment with donanemab regardless of tau level. This is not entirely accurate as some studies have shown a correlation between high levels of tau and poor response to amyloid plaque-targeting therapies like donanemab. Lastly, the article states that nearly half of clinical trial participants completed their course of treatment in six or 12 months. However, this statement does not provide any context for how long the study was conducted or what percentage of patients were able to complete their treatment regimen.
The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab.
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The article contains a statement that the FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab. This implies that there may be concerns about these aspects of the drug's development. Additionally, this is not typical for an advisory committee meeting as they are usually held after a decision has been made by the FDA. The fact that Lilly mentions it is unusual but looks forward to presenting their results suggests they understand there may be some bias in favor of donanemab.
]The FDA has informed Lilly 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.[
The FDA plans to hold a hearing of external advisers to explore how safe the therapy is and how well it works.
> Eli Lilly & Co.'s Alzheimer's disease drug donanemab faces further delays in gaining US approval.
The decision to hold an advisory panel hearing is a major surprise and comes just weeks before the FDA was expected to rule on approving the drug.
Accuracy
> The decision to hold an advisory panel hearing is a major surprise and comes just weeks before the FDA was expected to rule on approving the drug. '
The meeting date hasn't yet been set.
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The article contains a statement that suggests the FDA is concerned about the safety and efficacy of donanemab. This could be interpreted as an example of regulatory bias.
> The Food and Drug Administration wants to hear from outside experts <br>to further understand topics related to evaluating the safety and efficacy<br>of donanemab, Lilly said Friday in a statement.
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The author Robert Langreth and Madison Muller have conflicts of interest on the topics Alzheimer's disease, donanemab, Eli Lilly & Co., FDA hearing, external advisers and Food and Drug Administration (FDA). The article does not disclose these conflicts.
The author Robert Langreth is a former employee of Eli Lilly & Co. which developed the drug Donanemab.
