Priority Review Granted for Lecanemab by FDA

The Food and Drug Administration (FDA) granted priority review for traditional approval of the Alzheimer disease (AD) drug lecanemab-irmb (Leqembi; Eisai, Tokyo, Japan; and Biogen, Cambridge, MA) on March 6, 2023. This follows news from January 2023 which featured accelerated approval of the therapy by the FDA along with Eisai filing a supplemental Biologics License Application (sBLA) requesting that the FDA change the pathway from accelerated approval to traditional approval.

The FDA based their decision on data from the phase 3 Clarity AD clinical trial (NCT03887455). Results from this trial showed a reduction in amyloid beta (Aβ) plaques visualized in PET scans and slower cognitive decline in those who took lecanemab-irmb compared with those who took a placebo. The FDA also provided a prescription drug user fee act (PDUFA) action date of July 6, 2023 for a decision. In related news, the Centers for Medicare and Medicaid Services has reaffirmed its policy that restricts coverage for drugs used to treat AD only if they are approved under the FDA’s traditional review and approval process.

Lecanemab-irmb is a humanized immunoglobulin gamma 1 (lgG1) monoclonal antibody directed against aggregated soluble (“protofibril”) and insoluble forms of Aβ for the treatment of AD. The therapy is indicated for people diagnosed with AD with mild cognitive impairment or mild dementia stage of the disease and confirmed presence of Aβ pathology.

The most common adverse reactions from the drug were infusion-related reactions, headache, cough, and diarrhea.