Eisai, Biogen initiate rolling BLA to FDA for LEQEMBI

Eisai Co (ESAIY) and Biogen (BIIB) announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application, sBLA, to the FDA for lecanemab-irmb subcutaneous autoinjector, LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status. LEQEMBI is indicated for the treatment of Alzheimer’s disease n patients with Mild Cognitive Impairment or mild dementia stage of disease (collectively referred to as early AD). The sBLA is based on evaluation of subcutaneous lecanemab administration across a range of doses and as part of sub-studies within the Phase 3 Clarity AD open-label extension, following the 18-month core study in individuals with early AD. Should the FDA approve the LEQEMBI IQLIK 500 mg SC dosing regimen (two 250 mg injections), the autoinjector could be used to administer a once weekly starting dose, as an alternative to bi-weekly (every two weeks) intravenous dosing. This would expand the option for patients and care partners to receive LEQEMBI treatment from initiation to maintenance at home, offering a choice between IV and SC administration. The current injection time for each LEQEMBI IQLIK autoinjector takes approximately 15 seconds. The SC formulation also has the potential to reduce healthcare resources associated with IV maintenance dosing, such as preparation for infusion and nurse monitoring, while streamlining the overall AD treatment pathway.