The Food and Drug Administration approved on July 14 a new formulation of Leqembi, developed by Biogen and Eisai, allowing patients with Alzheimer’s disease to initiate treatment with an under-the-skin injection.
Previously, the subcutaneous version of Leqembi—marketed as Leqembi Iqlik—was only authorized for maintenance therapy after patients completed 18 months of intravenous initiation. The latest approval enables patients to begin their entire course of treatment at home using the subcutaneous option. This decision was granted more than a month ahead of the expected late August review date.
Biogen said in its news release that this makes Leqembi Iqlik the first anti-amyloid medicine worldwide to allow at-home dosing throughout all stages of therapy. BMO Capital Markets told investors that this offers “clear differentiation” from Eli Lilly’s Kisunla, which is administered intravenously. Analysts said, “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.”
Data supporting the FDA's decision came from sub-studies within the Phase 3 Clarity AD trial. According to Biogen's release, weekly injections provided equivalent drug exposure and similar clinical benefits compared with intravenous infusions. Safety profiles were also comparable between both forms.
The FDA had initially planned its decision by May 24 but postponed it by three months following a major amendment submission by Biogen and Eisai; the new target action date was set for August 24. With this early approval, Biogen said that Leqembi Iqlik will be available in U.S. pharmacies starting in August.
Jefferies wrote in a note that this regulatory nod “should materially improve competitiveness” versus Kisunla “by eliminating burdensome in-patient infusions.” While Kisunla offers finite dosing—with patients able to stop after four initial infusions if amyloid plaques drop sufficiently—Leqembi is designed for indefinite use. Early sales figures for Leqembi have lagged expectations; however, partners expect growth driven by what Jefferies called “improved subQ convenience.”
