WASHINGTON—U.S. officials granted full approval to a closely watched Alzheimer’s drug on Thursday, clearing the way for Medicare and other insurance plans to begin covering the treatment for people with the brain-robbing disease. The Food and Drug Administration endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s…
Alzheimer’s Drug Leqembi Gains FDA Panel’s Support for Full Approval
A group of independent advisers to the U.S. Food and Drug Administration (FDA) have voted to support regulatory approval of the Alzheimer’s drug Leqembi, also known by its generic name lecanemab, despite concerns surrounding three deaths during clinical trials. The six members on the Peripheral and Central Nervous System Drugs Advisory Committee on Friday all voted…
VHA to Cover Eisai, Biogen’s Alzheimer’s Drug for Eligible Veterans
The Veterans Health Administration (VHA) will provide coverage for Japanese company Eisai Co., Ltd and Biogen’s Alzheimer’s treatment Leqembi to eligible veterans living with early stages of Alzheimer’s disease, the companies announced on March 13. In order to be eligible for the drug, veterans will need to meet certain VHA criteria (pdf), such as having undergone an MRI scan within…
Lecanemab May Reverse Alzheimer’s Disease But 3 Deaths Raise Questions
The U.S. Food and Drug Administration (FDA) granted Leqembi accelerated approval on Jan. 6, 2023. It is the seventh drug the FDA has approved for the treatment of Alzheimer’s disease. The generic name of the drug is Lecanemab. It has been developed by the Japanese company Eisai in partnership with the U.S. company Biogen. These are…
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