In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at up-to-date safety data on Leqembi (lecanemab) at its next meeting in ...

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

The European medicines regulator said on Friday it will review safety information for Eisai and Biogen's Leqembi, nearly ...

The European Medicines Agency (EMA) announced it will review new safety data on the Alzheimer’s disease drug Leqembi (lecanemab). This follows a prior decision to recommend its use in the ...

The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's ...

Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the ...

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 ...

The sBLA is based on modeling of observed data from the Phase 2 study (Study ... before and continues after plaque removal. 1,2,3 Only LEQEMBI works to fight AD in two ways: continuously clearing ...

[1] In addition, recent data of three years of bi-weekly treatment across the Phase 3 Clarity AD core study and LTE, showed that Leqembi reduced cognitive decline on the CDR-SB by -0.95 relative ...