FDA approves Leqembi at-home subcutaneous injection in early Alzheimer’s

Key takeaways:

Leqembi Iqlik is the first approved in-home anti-amyloid injectable for early Alzheimer’s disease.

Patients treated with IV Leqembi have the option after 18 months to switch to 360 mg subcutaneous injection.

Perspective from Howard Fillit, MD

The FDA has approved a supplemental biologics application for Leqembi Iqlik subcutaneous injection for maintenance dosing in early-stage Alzheimer’s disease, paving the way for its marketing and distribution in the United States.

According to a press release from manufacturer Eisai, the newest formulation of Leqembi (lecanemab-irmb), a once-weekly injection in a 360 mg dose, which can be applied in 15 seconds for individuals with mild cognitive impairment or mild dementia, is expected to become available in the U.S. on Oct. 6.

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