US drug regulator on Thursday granted full approval to Alzheimer's drug Leqembi, manufactured by a Japanese firm Eisai. The company had earlier received conditional approval from the Food and Drug Administration (FDA) in January based on early results suggesting Leqembi worked on Alzheimer's patients by clearing a sticky brain plaque linked to the disease.
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Here are five points to know about the drug:
1. Leqembi is the first medicine shown to modestly slow the cognitive decline caused by Alzheimer's. The drug is among the most potent of a new generation of antibodies that help clear amyloid, a toxic protein that slowly builds up in the brains of Alzheimer’s patients.
2. The drug's prescribing information will carry the most serious type of warning, indicating that Leqembi can cause brain swelling and bleeding, side effects that can be dangerous in rare cases.
3. Leqembi is priced at about $26,500 for a year’s supply of intravenous every two weeks. Till now, the drug has only been shown to help patients at the earliest stages of the disease.
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4. Before prescribing, doctors need to confirm that patients have the brain plaque targeted by Leqembi. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.
{{/usCountry}}4. Before prescribing, doctors need to confirm that patients have the brain plaque targeted by Leqembi. Nurses need to be trained to administer the drug and patients must be monitored with repeated brain scans to check for swelling or bleeding. The imaging and administration services carry extra costs for hospitals beyond the drug itself.
{{/usCountry}}5. Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. The drug is co-marketed with Cambridge, Massachusetts-based Biogen.
(With AP, Bloomberg inputs)