BioArctic says Leqembi subcutaneous autoinjector shows efficacy, safety comparable to IV dosing in early Alzheimer’s disease

• BioArctic partner Eisai released AAIC 2026 data supporting weekly 500 mg Leqembi subcutaneous autoinjector as comparable to IV dosing in early Alzheimer’s.
• Bioequivalence reported versus IV initiation regimen, exposure ratio 104% with 90% CI 99.1%-109%.
• Clinical outcomes, amyloid reduction, ARIA-E rates tied to drug exposure rather than route, supporting a fixed-dose subcutaneous regimen across body weights.
• Safety profile broadly aligned with IV; injection-site reactions mainly local; anti-drug antibodies 1.4% with no neutralizing antibodies observed.
• US FDA priority review ongoing for subcutaneous initiation; PDUFA date set for Aug. 24, 2026.

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