The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has voted 6-0 in favor of granting full approval to Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. The decision is expected to result in full FDA approval on or before July 6th, as the agency usually follows its advisory committees' recommendations. The FDA released briefing documents that ..
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously supported Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease. This indicates that the FDA is likely to grant full approval before July 6th, as it usually follows its advisory committee's recommendations. The FDA released briefing documents on Wednesday that showed agency staff be..
The FDA's Peripheral and Central Nervous System Drugs Advisory Committee has unanimously voted in support of Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease, indicating that full approval is likely to be granted on or before July 6. The decision was based on clinical trial results showing consistently favorable outcomes for primary and secondary endpoints, includi..
The FDA is likely to grant full approval for Eisai and Biogen's Leqembi (lecanemab) for the treatment of Alzheimer's disease ahead of an advisory committee vote on the drug. The agency has asked the committee to confirm whether Study 301 results verify lecanemab's clinical benefit, but both the briefing documents and decision will be based on these results. The data from the trial consistently s..
The FDA is poised to grant full approval for Biogen and Eisai's Leqembi drug, which has been developed as a treatment for Alzheimer's disease. The decision is based on data from the pivotal trial Study 301, which showed consistently favorable results for primary and secondary endpoints. In July 2023, the FDA may grant full approval following a vote by an advisory committee that has been asked to..
