The Food and Drug Administration on Thursday granted full approval to Eisai’s and Biogen’s Alzheimer’s drug Leqembi, or lecanemab, marking the first drug in the class to receive the designation.
Nationally, Alzheimer’s disease affects an estimated 6.7 million people aged 65 and older. Black people are twice as likely to develop dementia than white people, and Hispanics are 1.5 times more likely.
The monoclonal antibody targets amyloid beta plaque buildup in the brain, and is approved for people in the early stages of the disease. The label also recommends genetic testing to measure the risk of side effects and to use caution if a patient is on blood thinners.