The FDA has granted full approval to Leqembi, a groundbreaking medication for Alzheimer's disease, developed by Eisai and Biogen. This follows the drug's initial accelerated approval in January. This marks a significant milestone, as Leqembi is the first amyloid beta-directed antibody to transition to traditional approval for Alzheimer's. The drug targets and reduces amyloid plaques in the brain, a key characteristic of the disease.

Medicare will cover Leqembi, requiring patients to enroll in a registry to monitor its effectiveness. Clinical trials demonstrated a 27% slowdown in Alzheimer's progression for individuals in the early stages of the disease. Alzheimer's, affecting 6.5 million Americans, is a progressive and irreversible brain disorder that impairs memory and cognitive function. Its exact cause remains unknown.

This full approval confirms Leqembi's clinical benefit in addressing the underlying disease process of Alzheimer's. This is a crucial step forward in treating this devastating condition. The FDA emphasized the drug's safety and effectiveness, while also noting a heightened risk of hemorrhages for patients on blood thinners. Leqembi is specifically approved for patients with mild dementia or cognitive impairment. Currently, there is no data supporting its use in earlier or later stages of the disease.