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

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..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 11.
  • textsms

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

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..

  • format_list_bulleted Pharmacology/BS
  • · 2023. 6. 10.
  • textsms