Biogen Receives FDA Approval for Subcutaneous Version of Leqembi for Alzheimer's Treatment

Biogen has secured FDA approval for a subcutaneous version of Leqembi, a treatment for early Alzheimer's disease. The new option allows patients to transition to a weekly maintenance dosing regimen using the SC autoinjector version, Leqembi Iqlik, after completing an 18-month course of biweekly infusions. This provides relief to AD patients, as IV administrations are time-consuming and can be done in about 15 seconds with Leqembi Iqlik. Biogen plans to commercially launch this version on Oct. 6, 2025.

Biogen has received FDA approval for a subcutaneous version of Leqembi, an innovative treatment for early Alzheimer's disease. The new formulation, Leqembi Iqlik, allows patients to transition to a weekly maintenance dosing regimen using a subcutaneous autoinjector after completing an 18-month course of biweekly infusions. This development marks a significant advancement in the treatment of early Alzheimer's disease, offering patients a more convenient and less time-consuming option.

The FDA approval is based on clinical trials supporting the safety and efficacy of the subcutaneous maintenance dosing. The BLA for Leqembi Iqlik was approved for maintenance dosing in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD. The clinical trials demonstrated that transitioning to the weekly subcutaneous injection maintains clinical and biomarker benefits comparable to continued IV dosing, with a similar safety profile [1].

The approval of Leqembi Iqlik provides patients with the ability to administer the treatment at home, reducing the burden of frequent hospital visits and allowing for more flexible treatment schedules. This development also has the potential to streamline healthcare resources, as it reduces the need for nurse monitoring and preparation for IV infusions, thereby increasing infusion capacity for new eligible patients [1].

Biogen plans to commercially launch Leqembi Iqlik on October 6, 2025, in the U.S. This new treatment option offers patients and care partners a more patient-centric approach to managing early Alzheimer's disease, while also providing healthcare providers with a new option for patients who are responding well to Leqembi and should continue treatment.

References:

[1] https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembir-iqliktm-lecanemab-irmb-subcutaneous