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

Fact checked by Nick Blackmer The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for ...

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

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

The U.S. Food and Drug Administration approved Eisai and Biogen’s application for IV maintenance dosing of lecanemab on January 27. Previously, the label called for biweekly IV dosing. The new ...

Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatmentAlzheimer's disease progression does ...

The US Food and Drug Administration has approved the supplemental biologics licence application (sBLA) of Eisai and Biogen's ...

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

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 ...

Modeling simulations predict that transitioning to once every 4 weeks maintenance dosing after 18 months of biweekly treatment will maintain clinical and biomarker benefits of therapy. Leqembi is ...

LEQEMBI ®) intravenous (IV) maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of ...

Additionally, the FDA accepted Eisai’s Supplemental Biologics License (BLA) for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing in January 2025 and set a PDUFA action date ...