The U.S. FDA approved the supplemental biologics license application (sBLA) for Eisai Co., Ltd., and Biogen Inc.’s LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use, making it the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

LEQEMBI demonstrated clinically meaningful slowing of cognitive and functional decline in a patient group generalizable to U.S. Medicare beneficiaries, which included a mix of racial and ethnic groups, patients with common comorbid conditions, concomitant medications and patients with mild cognitive impairment (MCI) due to AD or mild AD. Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

LEQEMBI’s traditional approval is based on Phase 3 data from Eisai’s large, global Clarity AD clinical trial, in which LEQEMBI met its primary endpoint and all key secondary endpoints with statistically significant results and confirmed the clinical benefit of LEQEMBI.

“Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer’s disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease,” said Haruo Naito, CEO Eisai. “As a research and development-focused company based on our hhc (human health care) concept, we are proud that the results of Eisai’s AD research over the past 40 years have been recognized and delivered to people living with this disease in the United States.”

Christopher Viehbacher, President, and CEO of Biogen said, “Today marks a breakthrough in the treatment of Alzheimer’s disease, and we are proud to be at the forefront of ushering in a new era of advances for a disease that was previously considered untreatable. We would like to express our sincere appreciation to those who have worked tirelessly to find a treatment for this unrelenting disease, without whom this progress would not be possible. “Our focus is now on the path forward, working alongside Eisai with the goal of making Leqembi accessible to eligible patients as soon as possible.”