FDA extends Leqembi Iqlik review timeline following major amendment
BioArctic announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental Biologics License Application (sBLA) for Leqembi Iqlik (lecanemab-irmb).
The new Prescription Drug User Fee Act (PDUFA) action date is now set for August 24, 2026, a three-month shift from the original timeline.
The extension follows a request from the FDA for additional information regarding the application.
Upon submission of the requested data, the agency classified the response as a "major amendment" to the sBLA, which automatically triggers a standard three-month extension to the review clock.
Despite the delay, BioArctic noted that the FDA has not raised any concerns regarding the approvability of the treatment to date.
The Leqembi Iqlik sBLA seeks approval for a subcutaneous auto-injector delivery system, designed to simplify the administration of the Alzheimer’s therapy for patients and caregivers.
This follows the successful FDA action on August 26, 2025, for Leqembi’s maintenance subcutaneous dosing, which moved the treatment closer to a more flexible, home-based administration model.
Leqembi is currently approved by more than 50 regulatory authorities globally, establishing it as a cornerstone treatment for slowing the progression of early Alzheimer’s disease.
The drug is being developed and commercialized globally through a partnership between BioArctic and Eisai, with Biogen (NASDAQ:BIIB) participating in the commercialization and manufacturing.
BioArctic remains focused on its operational preparations, including ongoing plans for joint Nordic commercialization alongside Eisai.
The company continues to receive royalties on global sales of Leqembi and maintains certain co-promotion rights in Northern Europe.
While the administrative delay pushes back the potential launch of the auto-injector format, the broader Leqembi franchise continues to see steady uptake as more healthcare systems integrate amyloid-beta directed therapies into standard neurology care