BioArctic AB's partner, Eisai, announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for less frequent monthly Leqembi™ intravenous (IV) maintenance dosing.
A Prescription Drug User Fee Act action date is January 25, 2025.
Leqembi (lecanemab-irmb) is a humanized immunoglobulin gamma 1 monoclonal antibody, not a preventive vaccine.
In the U.S., Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).
As of June 10, 2024, Leqembi is approved in Japan, China, and South Korea, and applications have been submitted for review in several countries, including the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, Taiwan, Singapore, and Switzerland.
As part of the monthly IV maintenance regimen, patients who have completed the biweekly IV initiation phase, the exact period under discussion with the FDA, would receive a less frequent monthly IV dose that maintains effective drug concentration to sustain the clearance of highly toxic amyloid beta (Aβ) protofibrils that can continue to cause neuronal injury.
The sBLA is based on the modeling of observed data from the Phase 2 study (Study 201) and its open-label extension (OLE), as well as the Clarity AD study (Study 301) and its OLE study.
Additionally, Eisai initiated the rolling submission of a BLA to the FDA for the Leqembi subcutaneous autoinjector for weekly maintenance dosing after the FDA granted it Fast Track designation in May 2024.
Alzheimer's disease is a progressive disease caused by toxic amyloid proteins. Once established, this pathophysiological process continues throughout the patient's life, so sustained treatment is necessary.
The company says treatment should be initiated early to maximize patient outcomes.
Data from Studies 201 and 301 and their OLEs show that continued therapy with LEQEMBI beyond the 18-month core phase prolongs the benefit as highly toxic protofibrils are continuously removed.
If approved, the clinical and biomarker benefits may be maintained through the once-monthly dosing regimen, which is less burdensome and makes it easier for patients and care partners to continue long-term.
BioArctic is a Swedish research-oriented biopharma company focused on neurodegenerative disorders. It has a broad and well-diversified project portfolio and the potential to improve patients' health.
