Following the FDA granting Fast Track designation, Eisai reports that it has completed its rolling submission of a Biologics License Application (BLA) to the FDA for Leqembi® (lecanemab-irmb) subcutaneous autoinjector for weekly maintenance dosing for the treatment of early Alzheimer’s Disease (AD).
The autoinjector will serve as a more convenient method of administration for patients at home or in medical facilities. The subcutaneous autoinjector weekly maintenance regimen will allow patients who have completed the biweekly intravenous initiation phase of treatment to receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils that can continue to cause neuronal injury even after the plaque has been cleared from the brain.
This news follows approval of Leqembi® in the UK for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease in August 2024. Leqembi® has previously been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in the European Union, Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland. In October 2024, Australia’s TGA decided against registering Leqembi® for these indications due to safety and efficacy concerns.