Research company Bioarctic has announced that its partner Eisai has received priority review from the U.S. Food and Drug Administration (FDA) for a supplemental application regarding Leqembi Iqlik as a subcutaneous autoinjector for weekly initiation therapy. A decision from the FDA is expected no later than May 24, 2026.

Leqembi is already approved in the United States for patients with mild cognitive impairment and mild Alzheimer's disease. If approved, the new injection form would become the first anti-amyloid treatment that can be administered at home both at the start of therapy and during maintenance. Additionally, the autoinjector can be used to deliver an initiation dose once a week, offering an alternative to the current intravenous dosing every other week.

The supplemental application is based on data from the phase 3 Clarity AD study. The supporting material includes substudies evaluating subcutaneous administration of multiple doses of lecanemab. These studies have been conducted as part of the open-label extension following the 18-month main study and include individuals with early Alzheimer's disease.