PR Newswire·Jul 13, 2026, 10:42 PM ET

FDA approves Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer's disease

BIOA

The US FDA approved a supplemental Biologics License Application for Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's disease.
The US launch of Leqembi Iqlik is scheduled for late August 2026.
Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment allowing at-home initiation & maintenance via an autoinjector instead of intravenous infusion.
The approved initiation regimen consists of 500 mg once weekly, delivered as two 250 mg injections administered over approximately 15 seconds each.
Patients may now receive the full treatment course via subcutaneous injection or intravenous infusion with the option to switch between methods as needed.
Clinical data from the Phase 3 Clarity AD long-term extension showed subcutaneous administration achieved exposure equivalent to intravenous dosing with similar efficacy & amyloid removal benefits.
Safety profiles for subcutaneous & intravenous administration are comparable regarding exposure-related adverse events such as ARIA-E, with no increase in isolated ARIA-H.
Injection-related reactions with the subcutaneous form were mostly localized, while systemic reactions were less frequent.
The new option aims to reduce clinic visit burdens, decrease reliance on infusion resources, & preserve infusion capacity for patients requiring intravenous therapy.
An autoinjector acceptability study indicated 94% of patients & care partners found the device easy to use with high satisfaction levels.
Leqembi is currently approved in 53 countries, with the subcutaneous formulation under regulatory review in 6 additional regions.
BioArctic holds commercialization rights in the Nordic region under its long-term collaboration with Eisai, which handles global regulatory & commercial activities.