FDA approves Leqembi (lecanemab) for monthly maintenance dosing for early Alzheimer’s disease – Eisai

The FDA has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease.

The decision follows a supplemental application from Eisai, which is codeveloping Leqembi with Biogen, based on the modeling of data from the Phase II Study 201 (NCT01767311) and the Phase III Clarity AD study (NCT03887455), and their long-term extension studies, showing that once-monthly dosing can help sustain the therapy’s beneficial effects.

“The approval of once every four-week maintenance dosing of Leqembi is an important step forward in improving the care and quality of life for people living with early Alzheimer’s disease, as well as their caregivers,” George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, said an organization press release. “We are hopeful that this milestone will drive further innovation and increase access to treatments that ease the burden on both patients and their caregivers facing this devastating disease.”

Alzheimer’s is characterized by the accumulation of toxic clumps of the protein amyloid-beta in the brain, which are thought to contribute to neurodegeneration and disease symptoms.

Given as intravenous (into-the-vein) injections, Leqembi is an antibody designed to bind and neutralize amyloid-beta protofibrils, the most neurotoxic form of the protein, which is expected to slow disease progression.