PR Newswire·Jul 13, 2026, 12:08 AM ET

New clinical data on the Leqembi® subcutaneous autoinjector presented at AAIC® 2026 support similar efficacy and safety to IV formulation in early Alzheimer's disease

BIOA

BioArctic AB's partner Eisai presented new data at the 2026 Alzheimer's Association International Conference showing the Leqembi subcutaneous autoinjector offers efficacy & safety comparable to intravenous administration in early Alzheimer's disease.
Once-weekly 500 mg subcutaneous dosing achieved bioequivalence to the IV initiation regimen with an exposure ratio of 104%, supporting similar clinical outcomes regardless of administration route.
Clinical efficacy, amyloid removal, & safety profiles are driven by drug exposure rather than the route of administration, with consistent results across all body weight quartiles supporting a fixed-dose regimen.
The subcutaneous formulation enables a fully at-home treatment pathway, allows switching between IV & subcutaneous options, & permits missed doses to be administered up to six days later.
Safety data indicates the subcutaneous profile aligns with IV data, featuring localized injection-related reactions, predicted similar ARIA-E incidence, & a low anti-drug antibody rate of 1.4% with no neutralizing antibodies.
Real-world data from two US centers showed slower cognitive decline over 36 months in 28 patients & 91% stability or improvement on MMSE scores for 10 of 11 evaluable patients receiving maintenance therapy.
Patient & care partner surveys reported high satisfaction (75-97%), convenience ratings (83-97%), & willingness to recommend the treatment (92-100%).
The US FDA granted Priority Review in January 2026 for the supplemental Biologics License Application regarding the subcutaneous starting dose, with an extended PDUFA date of August 24, 2026.
BioArctic holds commercialization rights for the Nordic region while Eisai manages global regulatory interactions & commercialization under their long-term collaboration agreement.