The sBLA of the drug candidate is backed by the results from the Clarity AD trial in which it met the primary endpoint as well as all key secondary endpoints
Eisai and Biogen announced that their jointly developed LEQEMBI (lecanemab-irmb) 100 mg/mL injection has been granted priority review by the US Food and Drug Administration (FDA) for Alzheimer’s Disease (AD).
The FDA has accepted Eisai’s supplemental Biologics License Application (sBLA) for the humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody. The sBLA backs the conversion of the drug candidate’s accelerated approval to traditional approval.
A decision on the full approval is expected to be taken by the regulator by 6 July 2023.
The IgG1 monoclonal antibody is designed to target aggregated soluble (protofibrils) and insoluble forms of amyloid beta (Aβ).
In January 2023, LEQEMBI received accelerated approval from the FDA based on the findings of a phase 2 study that showed the drug candidate decrease the build-up of Aβ plaque in the brain.
LEQEMBI is intended only for patients having mild cognitive impairment or mild dementia stage of disease and presence of Aβ pathology confirmed.
The sBLA of the drug is backed by the results from Eisai’s Clarity AD phase 3 clinical trial.
In the late-stage study, the drug candidate met the primary endpoint as well as all key secondary endpoints.
According to the FDA, data from the Clarity AD trial can be used as confirmatory study to validate lecanemab’s clinical benefit.
Both Eisai and US-based Biogen are co-commercialising and co-promoting the drug candidate with the former holding the final decision-making authority. The Japanese pharma company also leads the development of the IgG1 monoclonal antibody and regulatory filings globally.