The FDA has declined to grant accelerated approval to an experimental Alzheimer’s drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker
The US Food and Drug Administration declined to grant accelerated approval to an experimental Alzheimer’s drug, donanemab, and requested additional data from Eli Lilly and Company, the drug maker. The company, which announced the development on Thursday, plans to file Phase 3 clinical trial data later this year for a traditional FDA approval.
The Alzheimer’s Drug Discovery Foundation released a statement Thursday in response to the FDA decision, describing it as being due to “the limited number of patients” who stayed on donanemab for at least 12 months, which is the timeframe the FDA wants to see to assess the drug’s safety.
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