Eisai, a Japanese firm, and American drugs giant Biogen Inc (NASDAQ:BIIB) have received full Food and Drug Administration (FDA) approval for Leqembi, a groundbreaking drug that curbs Alzheimer's disease progression.
This approval represents a significant milestone as prior medications only addressed disease symptoms. Unlike its predecessors, Leqembi targets the brain's beta-amyloid protein, a potential Alzheimer's culprit.
Despite questions about cost, safety, and accessibility, the FDA gave its nod.
The treatment will cost approximately $26,000 annually, with the American Medicare system shouldering most of the expense.
While lauded for slowing disease progression by 27% over 18 months in those with mild cognitive impairment or early-stage Alzheimer's, Leqembi has faced criticism. It has been linked to brain swelling, haemorrhages, and even three deaths during trials.
Patients with mild cognitive impairment or early-stage Alzheimer's are eligible for Leqembi, administered intravenously biweekly.