A new dawn has arrived in the treatment of Alzheimer’s disease as the U.S. Food and Drug Administration (FDA) grants full approval for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection, representing a major leap forward in medical science. Developed by Eisai Co., Ltd. and Biogen Inc., LEQEMBI is the first-ever FDA-approved therapy to demonstrate significant effectiveness in slowing cognitive decline and reducing the rate of disease progression in adults with Alzheimer’s.
The groundbreaking approval comes on the heels of promising Phase 3 results from the Clarity AD clinical trial, which showcased LEQEMBI’s potential to revolutionize Alzheimer’s treatment. Patients receiving LEQEMBI experienced a remarkable 27% reduction in Clinical Dementia Rating Sum of Boxes (CDR-SB) after 18 months compared to those in the placebo group. Furthermore, the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL) revealed a notable 37% improvement, indicating enhanced independence in daily activities.
One of the most significant developments following the FDA’s approval is the expansion of LEQEMBI’s coverage by the Centers for Medicare & Medicaid Services (CMS). This expansion promises increased accessibility, ensuring more individuals have the opportunity to benefit from this groundbreaking treatment. It is anticipated that this move will facilitate smoother reimbursement processes across a wide range of healthcare settings in the United States.
Haruo Naito, CEO at Eisai, expressed profound pride in the recognition of Eisai’s four-decade-long research efforts in Alzheimer’s disease. Christopher A. Viehbacher, CEO of Biogen, hailed this as a breakthrough, marking a new era of advancements for a previously considered untreatable disease.
It is important to note that, like other medications targeting amyloid beta, LEQEMBI may lead to amyloid-related imaging abnormalities (ARIA), including ARIA with edema (ARIA-E) and ARIA with hemosiderin deposition (ARIA-H). The incidence of ARIA can vary among treatments, but it typically occurs early in the treatment process.
LEQEMBI represents a significant stride in Alzheimer’s treatment, offering hope to individuals and their families affected by this devastating disease. Continued research and development in this field are critical for further advancements and to improve the lives of those living with Alzheimer’s.