for intravenous use Initial U.S. Approval: 2023
As specified in the prescribing information, Leqembi is indicated for the treatment of Alzheimer’s disease. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.
Facts about lecanemab-irmb injection
DOSAGE FORMS AND STRENGTHS: Package
• 500 mg/5 mL (100 mg/mL) solution in a single-dose vial.
• 200 mg/2 mL (100 mg/mL) solution in a single-dose vial.
DISEASE INDICATIONS: Alzheimer’s disease
MANUFACTURER: Eisai Europe Ltd
MEDICINE APPROVED BY: Food and Drug Administration (FDA)
- Full prescribing information [FDA]: (PDF) Click Here
- FDA grants accelerated approval for Alzheimer’s disease treatment FDA, January 2023
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