FDA approves lecanemab for the treatment of Alzheimer’s disease
The U.S. Food and Drug Administration (FDA) has granted approval for the supplemental Biologics License Application (sBLA) supporting the traditional approval of Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use, according to a press release. This approval makes Leqembi the first and only treatment demonstrated to reduce the rate of disease progression and slow cognitive and functional decline in adults suffering from Alzheimer’s disease (AD).
Leqembi showed efficacy in slowing cognitive and functional decline in a patient group representative of U.S. Medicare beneficiaries, encompassing various racial and ethnic backgrounds, patients with common comorbid conditions, individuals taking concomitant medications, and those with mild cognitive impairment (MCI) due to AD or mild AD. As a result, Leqembi should be initiated in patients with MCI or mild dementia stage of the disease, which is collectively referred to as early AD—the population in which the treatment was initiated during clinical trials.
The traditional approval of Leqembi is based on Phase 3 data derived global Clarity AD clinical trial. The trial demonstrated that Leqembi met its primary endpoint and all key secondary endpoints, yielding statistically significant results that confirmed the clinical benefit of the treatment. The primary endpoint, the Clinical Dementia Rating Sum of Boxes (CDR-SB)—a global cognitive and functional scale—indicated a 27% reduction in clinical decline on CDR-SB at 18 months compared to the placebo. Furthermore, the secondary endpoint, the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL), measured a significant benefit of 37% based on reports from caregivers of AD patients. This measurement evaluates patients’ ability to function independently, including tasks such as dressing, feeding themselves, and engaging in community activities.
Read the full press release here.
