Lecanemab wins full regulatory approval

The US Food and Drug Administration has granted traditional approval to Eisai and Biogen’s Alzheimer’s therapy lecanemab, making the drug the first in its class to fully gain the green light . Marketed as Leqembi, the monoclonal antibody treatment slows disease progression by clearing amyloid-β protein deposits in the brains of people with Alzheimer’s disease. According to the FDA press release , lecanemab is primarily intended for patients with mild cognitive impairment owing to early-stage Alzheimer’s disease. The drug’s prescription includes a boxed warning about the potential hazards: lecanemab carries the risk of cerebral swelling and hemorrhaging , collectively known as amyloid-related imaging abnormalities (ARIA). The risk of brain swelling, in particular, is higher for people who carry two copies of the apolipoprotein E4 gene than for those bearing only one genetic copy or none. Moreover, at least three deaths occurred among Phase 3 clinical trial participants who were on © 2023 Chemical & Engineering News