FDA grants full approval to Leqembi, opening up coverage of Alzheimer’s drug by Medicare
For the first time in 20 years, the FDA has bestowed full approval on a drug to treat Alzheimer’s disease, opening the door to coverage for millions of Medicare recipients.
While Eisai and Biogen’s drug Leqembi had been available since January after the FDA cleared it through the accelerated approval pathway, the lack of reimbursement from Medicare had been a major barrier for its uptake.
“Today is a triumph for the Alzheimer’s disease community after so many years of hard work by scientists, clinicians, and clinical trial participants,” Eisai’s US chairman and CEO Ivan Cheung told Endpoints News in an interview. “This is a very humbling moment. I personally wish this would have come many years earlier.”
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