FDA advisers recommend full approval for Alzheimer's drug Leqembi.
TL;DR Summary
Independent advisers to the FDA have unanimously agreed that Leqembi, a new Alzheimer's drug, benefits patients, all but ensuring the medication will be the first of its class to get full approval for the memory-robbing illness. The FDA is expected to grant Leqembi regular approval by early July. The medication, which is made by Eisai and Biogen, is administered intravenously twice a month and is designed for people with mild cognitive impairment or early dementia caused by Alzheimer's. The drug is priced at $26,500 a year and has the potential to cause serious side effects, including brain swelling and bleeding.
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- Eisai, Biogen's Leqembi passes muster at FDA adcomm FiercePharma
- FDA advisers endorse Alzheimer’s drug for full approval The Hill
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