The first Alzheimer's drug proven to slow disease progression receives FDA approval
The US Food and Drug Administration (FDA) has granted full approval to the groundbreaking Alzheimer's drug, Leqembi, marking the first medication with proven efficacy in slowing the progression of this devastating disease. This announcement has also prompted the Centers for Medicare and Medicaid Services (CMS) to expand coverage of the drug, providing access to an estimated one million individuals in the early stages of Alzheimer's. Read on.
A milestone achievement in Alzheimer's treatment
Leqembi, developed by Eisai and Biogen, initially received accelerated approval in January based on its ability to clear amyloid plaque buildups in the brain associated with Alzheimer's disease. However, due to CMS's earlier coverage decision, access to the drug has been limited. Now, with full FDA approval, Medicare coverage will be broadened, addressing the financial burden faced by patients. The drug's annual cost of $26,500 before insurance coverage has been a major obstacle for many individuals, making expanded Medicare coverage a significant breakthrough.
The approved use of Leqembi is specifically for individuals in the early stages of Alzheimer's, including those with mild cognitive impairment or mild dementia, who have confirmed amyloid plaques in their brains. According to Dr. Lawrence Honig, a neurology professor at Columbia University Irving Medical Center, this group comprises roughly one-sixth of the more than six million Americans diagnosed with Alzheimer's. Although Leqembi is not a cure, an 18-month clinical trial demonstrated a 27% slowdown in cognitive decline and functional impairments, offering patients more time to maintain their independence and engage in the activities they cherish.
The road ahead and potential challenges
Despite the approval, there are important considerations regarding the use of Leqembi. Patients with more advanced stages of Alzheimer's may not experience significant benefits from the drug and could face increased safety risks. Dr. Honig emphasizes the need for ongoing research to develop more efficacious treatments. Leqembi's approval also has potential side effects, including brain swelling or bleeding. The FDA has included a boxed warning to inform patients and caregivers about these risks.
Furthermore, the expanded Medicare coverage for Leqembi may result in higher Medicare Part B premiums for all enrollees due to the increased spending. KFF analysis suggests that if 10% of the estimated 6.7 million older adults take Leqembi, it could raise spending by $17.8 billion. However, the Alzheimer's Association welcomes the FDA's decision, acknowledging that it will grant individuals in the early stages of the disease valuable additional time to engage in meaningful activities and maintain their relationships.