Eli Lilly says U.S. FDA rejects accelerated approval for Alzheimer’s drug

Published by
Reuters

By Deena Beasley (Reuters) -Eli Lilly and Co on Thursday said the U.S. Food and Drug Administration has rejected accelerated approval of its experimental Alzheimer’s drug because it did not submit enough trial data from patients who were treated for at least 12 months. Lilly said the FDA sent it a complete response letter for donanemab, an antibody designed to remove amyloid protein plaques from the brains of people with early Alzheimer’s. Such letters typically outline concerns and conditions that must be addressed to gain U.S. approval. Lilly said the FDA issued the letter “due to the limite…

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