Leqembi Iqlik can now be given at home throughout the entire course of treatment, setting it apart from Eli Lilly’s Kisunla, the only other anti-amyloid Alzheimer’s disease therapy on the market.
The FDA has signed off on Biogen and Eisai’s under-the-skin formulation of Leqembi to initiate treatment for patients with Alzheimer’s disease.
The injection, called Leqembi Iqlik, was first approved in August 2025, but only for the maintenance treatment of patients who have completed 18 months of intravenous initiation therapy. This latest approval, granted Monday, gives patients the option to start their treatment regimen with a subcutaneous therapy.
The nod also makes Leqembi Iqlik the first and so far only anti-amyloid medicine worldwide that allows at-home dosing throughout the entire course of treatment, Biogen said in its news release. This dosing profile provides the Leqembi franchise with “clear differentiation” over its key competitor, Eli Lilly’s Kisunla, which is given intravenously, BMO Capital Markets told investors in a Monday note.
“We view approval of subQ initiation as a meaningful positive for future Leqembi uptake, allowing patients who struggle to travel to treatment or require caregiver transport to gain access to beta-amyloid therapy from their own home,” the analysts said.
Data from sub-studies under the Phase 3 Clarity AD trial supported the FDA’s decision, according to Biogen’s release. A weekly under-the-skin injection achieved equivalent drug exposure to intravenous infusion, indicating similar clinical and biomarker benefits. Safety was likewise comparable to intravenous Leqembi.
Leqembi Iqlik for initiation will be available on U.S. shelves starting in August, Biogen said.
Like BMO, Jefferies considers the approval a key win for Biogen and Eisai, writing in a Monday note that the nod “should materially improve competitiveness” versus Kisunla “by eliminating burdensome in-patient infusions.” Kisunla won regulatory clearance in July 2024, more than a year after Leqembi’s January 2023 accelerated approval, which was converted to full approval in July that year.
Kisunla is attractive to providers in the early treatment space due to its finite dosing duration, the firm explained: After four initial infusions, patients are allowed to stop treatment once amyloid plaques drop beyond a certain level on PET scans. Leqembi, in contrast, is given indefinitely.
Leqembi has had a rough time in the market, with early sales figures underwhelming investors. In March 2025, Eisai was forced to lower its total revenue projections for Leqembi for the 2025 fiscal year due to slow uptake. Sales have started picking up—and with Monday’s approval, the partners could see more growth for the Leqembi franchise, driven by what Jefferies called “improved subQ convenience.”
