The Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the monthly intravenous (IV) maintenance regimen of Leqembi ® (lecanemab-irmb ...
Eisai has filed to extend the label for its Alzheimer’s disease therapy Leqembi to include a maintenance ... that is specific to the subcutaneous form. In a statement, Eisai and Biogen said ...
The agency has set a Prescription Drug User Fee Act (PDUFA) action date for the weekly autoinjector form of Leqembi for 31 August 2025. Eisai and Biogen’s antibody is currently infused every two ...
With this approval, patients who receive the anti-amyloid drug biweekly for 18 months can then consider switching to a monthly dosing regimen.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback