Leqembi Receives FDA Approval for Monthly Maintenance Dosing

Eisai and Biogen announce FDA approval for monthly maintenance dosing of Leqembi, their Alzheimer's drug. Initially approved in 2023, Leqembi has faced slow growth due to administration challenges.

Simplified Administration

Patients can now transition to monthly dosing after 18 months of biweekly intravenous infusions. This change reduces the burden of regular MRIs and screenings, making the treatment more accessible.

Sustained Benefits

Modeling data suggests that monthly maintenance dosing preserves the therapeutic benefits of Leqembi. The drug targets amyloid beta plaques in the brain, a key feature of Alzheimer's.

Comparison with Rival Drug

Eli Lilly's Kisunla, a competing Alzheimer's drug, is also given monthly and discontinues treatment when amyloid plaques are no longer detected.

Safety Considerations

Both Leqembi and Kisunla carry safety warnings for potential brain swelling and bleeds. Regular scans are recommended for monitoring.

Collaboration

Eisai has partnered with BioArctic for the development of Leqembi.