Eisai and Biogen FDA Review Period Extended to August 24
Eisai (ESAIY) and Biogen (BIIB) announced that the FDA has extended the review period by three months for the supplemental biologics license application, or sBLA, for a once-weekly lecanemab-irmb subcutaneous injection as a starting dose for the treatment of early Alzheimer's disease. The new Prescription Drug User Fee Act action date is August 24. As part of the ongoing review process, the agency requested additional information and has determined that it constituted a major amendment to the sBLA, extending the PDUFA date to allow sufficient time for a full review of the additional materials. The FDA has not raised any concerns to date regarding the approvability of Leqembi Iqlik as a starting dose. Eisai and Biogen believe that the clinical data package evaluating subcutaneous administration of Leqembi across multiple studies and dosing regimens strongly supports the potential use of Leqembi Iqlik for initiation therapy, following FDA approval of the subcutaneous maintenance dosing regimen on August 26.
