Developed by Eisai and Biogen, Leqembi is humanised IgG1 monoclonal antibody indicated as an AD therapy for patients with mild cognitive impairment or mild dementia
Eisai files sBLA to FDA for IV maintenance dosing of Leqembi in AD treatment. (Credit: Tumisu from Pixabay)
Eisai has submitted the supplemental biologics license application (sBLA) to the US Food and Drug Administration (FDA) for the use of Leqembi (lecanemab-irmb) in intravenous (IV) maintenance dosing for the treatment of early Alzheimer’s disease (AD).
Developed by Eisai and Biogen, Leqembi is a humanised immunoglobulin gamma 1 (IgG1) monoclonal antibody indicated in the US as an AD therapy for patients with mild cognitive impairment or mild dementia.
Under the monthly IV maintenance regimen, patients who have finished the biweekly IV initiation phase, with the specific duration determined in consultation with the FDA, will receive a monthly IV dosage.
This dosage is designed to uphold an effective drug concentration, ensuring the continual clearance of highly toxic protofibrils. These protofibrils can persist in causing neuronal damage even after the removal of amyloid-beta (Aβ) plaques from the brain.
The sBLA is supported by modelling of data observed from the Clarity AD study and its open-label extension (OLE) study as well as a Phase 2 study and its OLE.
In March, Eisai planned to file a biologics license application (BLA) for weekly maintenance therapy administered by subcutaneous (SC) injection.
Under the current fast track and breakthrough therapy designations, the Japanese pharmaceutical company intended to start a rolling BLA for lecanemab SC maintenance in March.
This was in response to the FDA’s recent request for additional three-month immunogenicity data at the proposed maintenance dose of weekly 360mg.
Eisai was recently notified by the regulator that rolling review requires a fast track designation specific to the SC formulation.
The pharma company filed a request for fast track designation for the SC formulation by the guidelines. Eisai will start the rolling submission upon receiving this designation from the FDA.
Additionally, Eisai has submitted applications for review to the European Union, Australia, Canada, the UK, Russia, and other countries.
Currently, the AD therapy is authorised in the US, Japan, and China.
In October last year, Eisai and Biogen announced positive results for Leqembi in both SC formulation and IV administration.