(News Bulletin 247) – Eisai and Biogen have announced that the FDA has granted traditional approval for LEQEMBI® (lecanemab-irmb) for the treatment of Alzheimer’s disease.
‘ The United States Food and Drug Administration (FDA) has approved the Supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s disease (AD),’ the group says.
LEQEMBI demonstrated clinically significant slowing of cognitive and functional decline in a group of patients.
Treatment with LEQEMBI should be initiated in patients with MCI or mild stage dementia, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
‘Alzheimer’s disease is a progressive and fatal disease that has a profound impact not only on the people who have it, but also on their loved ones, their care partners and society. We continue to work to create broad and easy access to LEQEMBI for patients and to support diagnosis and treatment at the early stage of the disease,” said Haruo Naito, Chief Executive Officer of Eisai.
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