Client news: FDA grants traditional approval for LEQEMBI® (LECANEMAB-IRMB) for the treatment of Alzheimer’s Disease.
ScandicNeuro Corp congratulates Eisai Co., Ltd., and Biogen Inc., along with all parties involved in the clinical trial that led to the U.S. Food and Drug Administration’s (FDA) approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use. This marks the first and only approved treatment shown to reduce the rate of the disease progression and to slow cognitive and functional decline in adults diagnosed with Alzheimer’s disease.
Our company provided consulting services throughout Phase 3 of this clinical trial in which LEQEMBI® met its primary endpoint and all key secondary endpoints with statistically significant results confirming its clinical benefit. This approval allows Medicare to cover this important therapy for appropriate patients and facilitate reimbursement for, and access to, LEQEMBI® across healthcare settings in the United States. To read more about this approval, click on link for Eisai’s press release: