Eisai Initiates Rolling Submission of Supplemental Biologics License Application for Leqembi Iqlik to FDA

Strategic Insights -

Eisai has initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Leqembi Iqlik, a subcutaneous autoinjector for the treatment of Alzheimer's disease. This submission follows the approval of Leqembi Iqlik for maintenance dosing in the US on August 29. If approved, Leqembi Iqlik would be the first and only anti-amyloid treatment to offer at-home injection from the start, helping patients and care partners treat this progressive, deadly disease.

Key Takeaways:

  • Eisai initiated a rolling submission of the Supplemental Biologics License Application (sBLA) to the FDA for Leqembi Iqlik, a subcutaneous autoinjector for the treatment of Alzheimer's disease.
  • The sBLA is based on evaluation of subcutaneous (SC) lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension.
  • Leqembi Iqlik's SC formulation has the potential to reduce healthcare resources associated with IV dosing and streamline the overall AD treatment pathway.
  • The current injection time for each Leqembi Iqlik autoinjector takes approximately 15 seconds.
  • Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease.
  • Eisai is responsible for the clinical development, applications for market approval, and commercialization of Leqembi for Alzheimer's disease, while BioArctic has the right to commercialize Leqembi in the Nordic region together with Eisai.

Statistics:

  • 48 countries have approved Leqembi, while 10 countries are under regulatory review.
  • The SC formulation of Leqembi Iqlik takes approximately 15 seconds for each injection.
  • Bi-weekly (every two weeks) intravenous (IV) dosing of Leqembi is currently the standard treatment option.

Sources:

  • NewsRx - "BioArctic's partner Eisai initiates rolling submission of supplemental biologics license application for Leqembi Iqlik to US FDA" (September 3, 2025)