FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s

Back to news list

Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/fda-review-eisais-leqembi-sbla/...

Published: Tue, 27 Jan 2026 09:11:31 +0000

The FDA has accepted a request from Eisai and Biogen to review a new filing for Leqembi Iqlik that would allow patients with early-onset Alzheimer's disease to administer the drug at home by subcutaneous injection instead of intravenous administration in a hospital[2]. The new regimen would be a weekly dose of 500 mg administered as two 250 mg injections, which should provide the same efficacy as the current biweekly intravenous administration[2]. If the FDA approves this filing, Leqembi Iqlik would become the first and only anti-amyloid drug to offer both initiation and maintenance treatment at home[1]. The FDA will decide on approval by May 24, 2026[1][2]. Research studies have shown that a weekly subcutaneous dose of 500 mg achieves exposure equivalent to biweekly intravenous administration with similar clinical outcomes and safety, with less than 2% of patients experiencing infusion or injection reactions[2]. In August 2025, the FDA already approved Leqembi Iqlik 360 mg for weekly subcutaneous maintenance treatment after 18 months of intravenous treatment[2].