Eisai and Biogen Announce the Traditional Approval for LEQEMBI® (lecanemab-irmb)
Friday, July 07, 2023
Eisai and Biogen announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics Licence Application (sBLA) for LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use.
This approval marks LEQEMBI as the first and currently only treatment to receive approval for reducing the rate of disease progression and slowing cognitive and functional decline in adults with Alzheimer's disease (AD).
The clinical trials of LEQEMBI demonstrated significant slowing of cognitive and functional decline in a diverse patient group that represents U.S. Medicare beneficiaries. This group included individuals from different racial and ethnic backgrounds, patients with common comorbid conditions, those taking concomitant medications, and individuals with mild cognitive impairment (MCI) due to AD or mild AD.
In clinical trials, treatment with LEQEMBI was initiated in patients diagnosed with mild cognitive impairment (MCI) or mild dementia, collectively known as early Alzheimer's disease (AD). It is recommended that LEQEMBI treatment be initiated in individuals within this population, as these trials demonstrated the efficacy and safety of the medication specifically in patients at the early stages of the disease.
The approval of LEQEMBI by the FDA marks a significant milestone, as it is the first and only anti-amyloid therapy to receive approval for AD treatment under the traditional approval pathway.
