- Eli Lilly & Company, the maker of anti-amyloid Alzheimer’s treatments, was expecting its experimental drug donanemab to be approved by the FDA this month.
- However, the FDA has said it will hold a panel with external advisors to evaluate the safety and efficacy of donanemab before it makes a decision later this year.
- Although the FDA’s decision was a surprise, some experts say a more cautious approach would be beneficial for patients, considering the drug is in early trials and there is little evidence of its benefits.
Eli Lilly announced Friday that the U.S. Food and Drug Administration (FDA) had established a committee to evaluate donanemab, the Alzheimer’s drug that had its approval blocked last year. The committee is expected to convene later this year before the FDA makes a final decision about approving donanemab. The announcement, however, has come as a surprise for many.
But what does this decision mean for Alzheimer’s patients? Here’s what experts think.
Donanemab is one of three
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Dr. Howard Fillit, MD, co-founder and chief science officer of the Alzheimer’s Drug Discovery Foundation (ADDF), told Medical News Today that while such a committee is not unusual for a…
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