FDA

Subcutaneous Leqembi Iqlik OK’d for maintenance dosing in early Alzheimer’s

September 3, 2025

Brand name: Leqembi Iqlik

Generic name: lecanemab-irmb SC injection

Manufacturer: Biogen

Approval date: August 29, 2025

FDA approved Leqembi Iqlik (lecanemab-irmb subcutaneous injection) for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). After 18 months of Leqembi (lecanemab-irmb) IV treatment at 10 mg/kg every two weeks, patients may either continue IV infusions at 10 mg/kg once every four weeks or start the new weekly 360 mg SC injection using the Leqembi Iqlik autoinjector.

Efficacy

Approval was based on data from Leqembi SC sub-studies of the phase 3 Clarity AD open-label extension (OLE) trial in individuals with early AD, which evaluated a range of SC doses. Results showed that transitioning to the weekly Leqembi Iqlik autoinjector after 18 months of the initiation dose (10 mg/kg IV every two weeks) maintains clinical and biomarker benefits comparable to continued IV dosing.

Safety

The safety of Leqembi Iqlik autoinjector was studied in >600 patients at a range of doses as part of the Clarity AD OLE. A total of 49 patients received a weekly 360 mg SC maintenance dose after at least 18 months of 10 mg/kg IV every two weeks. None of these patients experienced any local or systemic injection-related adverse events.

Across all SC doses, the safety profile was similar to that of the IV maintenance treatment with one key difference: systemic reactions were much less common with SC dosing—<1% vs. approximately 26% with IV infusions. Approximately 11% of patients experienced mild-to-moderate local reactions (eg, redness, swelling or itching at the injection site), which didn’t interfere with continued administration, and <1% had mild systemic symptoms such as headache, fever, or fatigue.

Rate of amyloid-related imaging abnormalities (ARIA) in patients who received a weekly 360 mg SC maintenance dose were similar to ARIA rates reported in patients who continued with the IV dose after 18 months and are similar to the background rates of ARIA in patients without treatment.

Sources:

FDA Approves LEQEMBI® IQLIK™ (lecanemab-irmb) Subcutaneous Injection for Maintenance Dosing for the Treatment of Early Alzheimer's Disease. [News release]. 2025. https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous

Leqembi Iqlik (lecanameb-irmb) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761375s000lbl.pdf Revised August 2025. Accessed September 3, 2025.