FDA Adcomm Unanimously Backs Full Approval of Eisai, Biogen’s Leqembi

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 ..