Eisai and Biogen have completed their rolling biologics license application in the US for a subcutaneous formulation of Alzheimer's disease therapy Leqembi previously delayed by the FDA on
Australia's Therapeutic Goods Administration (TGA) has said it won't approve Eisai and Biogen's Alzheimer's disease therapy Leqembi, saying its efficacy does not outweigh its risks.
The UK drugs regulator has approved Eisai and Biogen's Alzheimer's disease therapy Leqembi, shortly after an EU committee turned it down on the grounds that its modest efficacy did not outw
Eisai and Biogen have reported data showing that the benefit of treatment with their Alzheimer's disease therapy Leqembi appears to build over time, with no increase in safety risks.
The EMA's human medicines committee has recommended against approval of Eisai and Biogen's Alzheimer's disease therapy Leqembi, after regulators in the US, China, and Japan gave a green lig
At ASCO 2024 last month, editor-in-chief Jonah Comstock caught up with Dr Andree Amelsberg, SVP of global and US medical affairs at Eisai, to chat about what the company was sharing at the