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FDA Approves Under-the-Skin Form of Drug for Maintenance Treatment of Alzheimer’s Disease

Treatment Can Be Used for At-Home Administration

On Aug. 29, the U.S. Food and Drug Administration (FDA) approved Leqembi Iqlik (lecanemab-irmb) subcutaneous (under-the-skin) injection for maintenance treatment of adults with Alzheimer’s disease. Leqembi Iqlik is indicated for patients who have completed at least 18 months of treatment with intravenous (administered into the vein) Leqembi. Leqembi Iqlik is the first amyloid beta-directed antibody approved for home administration by a patient or caregiver.

A patient or caregiver administers Leqembi Iqlik subcutaneous injection 360 mg once a week using the Leqembi Iqlik autoinjector. The most common side effects include localized injection-related reactions (e.g., pain, redness, and itching), and amyloid-related imaging abnormalities (ARIA), which can be serious and potentially fatal. A boxed warning is included in the prescribing information to alert patients and caregivers to the potential risks associated with ARIA. Safety was otherwise like what was observed with intravenous Leqembi.

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