SubQ Biogen and Eisai could be forced to wait another three months to hear the verdict from the FDA on their plan to begin treating patients with their anti-amyloid Alzheimer’s drug in an under-the-skin version.
The FDA has asked for more data related to the proposed use of subcutaneous Leqembi in treatment initiation as part of its drug review process, the pharma partners said. The regulator next considered the companies’ application a “significant modification” to the application and delayed the target action date.
The original deadline for the FDA to decide was May 24th. Biogen and Eisai are awaiting the decision, which they hope will be issued by August 24.
As for how the delay would affect the company, RBC Capital Markets analysts see it as “limited” in both scenarios, in a note to investors. In either case, reimbursements for the drug “would not have occurred until 2027,” the analysts said.
The delay “pushes out a catalyst we believe the Street had been keying in on to give visibility around medium term Leqembi growth acceleration and introduces incremental risk” to Biogen, RBC added, “but should get resolved.”
In January 2023, Leqembi was first approved via the FDA’s accelerated approval pathway for Alzheimer’s, and was the first anti-amyloid antibody drug to secure the agency’s full approval in July 2023. Leqembi is given intravenously, over 1 hour, once every 2 weeks.
In September 2025, the FDA cleared a new formulation of Leqembi, Leqembi Iqlik, that allowed the drug to be administered via an under-the-skin injection—a more convenient route of administration that also opened the option of at-home treatments. The approval of this, however, was only for maintenance treatments. New patients would still have to undergo an 18-month induction period.
Biogen and Eisai are now suggesting utilizing this subcutaneous formulation to start patients, thus avoiding any need for IV infusions. Leqembi Iqlik, which is administered every week, was shown to have bioequivalent drug exposure to the IV version administered every two weeks, the partners said in a news release issued in January 2026 to support their application.
The safety profile of both formulations of Leqembi was comparable, the companies added.
If approved, Leqembi Iqlik would be the first anti-amyloid therapy that offers patients at-home, subcutaneous dosing for the entirety of their treatment journey, Biogen and Eisai said in January. A nod would also enable them to be more competitive with Eli Lilly’s Kisunla when it comes to convenience.
An approval is “going to be extremely important,” Chris Viehbacher, Biogen’s CEO, said at the J.P. Morgan Healthcare Conference in January. Kisunla is infused once every month, while Leqembi is infused twice a month. Viehbacher said the convenience advantage Kisunla enjoys will disappear when a subcutaneous version is available.
This subcutaneous at-home therapy also fits into Biogen’s plans to target patients who are not only at the end of the treatment with Kisunla but would like to switch to another treatment.
The first batch of Kisunla-treated patients are set to end their 18-month treatment period, Alisha Alaimo, Biogen’s head of North America, said during the company’s Q1 call on April 29. “Physicians are asking, what do we do? Patients in general, who are on either of the products, want to be on the product; there is a fear of coming off and having a decline in their cognition.”
Biogen and Eisai have encountered a setback after regulators imposed a three-month delay on the initiation of their Subcutaneous (SubQ) Alzheimer’s treatment program. The decision affects the planned rollout timeline for Biogen and Eisai as they continue advancing next-generation therapies for Alzheimer’s disease.
Overview of the Biogen and Eisai SubQ Program
The SubQ formulation is designed to offer a more convenient administration method compared to traditional intravenous infusion therapies. This approach aims to improve patient accessibility, reduce clinic visit times, and enhance long-term treatment adherence.
Biogen and Eisai have been collaborating closely on Alzheimer’s disease therapies, building on their existing portfolio of amyloid-targeting treatments.
Biogen and Eisai have reportedly been hit with a three-month delay in initiating their SubQ (subcutaneous) Alzheimer’s treatment program. The setback affects planned clinical and regulatory timelines for their next-generation SubQ formulation designed to improve patient convenience and treatment delivery.
What is SubQ Alzheimer’s Treatment?
The SubQ Alzheimer’s treatment refers to a subcutaneous formulation intended to provide a more convenient alternative to intravenous (IV) infusions. The SubQ approach aims to simplify administration, potentially allowing patients or caregivers to receive treatment outside hospital settings.
Biogen and Eisai have been actively developing SubQ versions of Alzheimer’s therapies to improve accessibility and reduce healthcare system burden.
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