A decision on the approval under the Prescription Drug User Fee Act (PDUFA) is anticipated on 25 January 2025.
LEQEMBI is intended to treat AD patients having mild cognitive impairment or mild dementia stage of disease (together called early AD).
People who have concluded the biweekly IV initiation phase could now receive a monthly IV dose that will aid in preserving the effective drug concentration to continue the protofibrils clearance which otherwise could lead to neuronal injury.
The sBLA is based on the modelling of observed data from a Phase II trial, Study 201, and its open-label extension (OLE) part as well as the Clarity AD study (Study 301) and its OLE study.
Data from Studies 201, 301 and their OLEs demonstrated that LEQEMBI treatment beyond the initial 18-month phase could lengthen the benefit of removing protofibrils.
On receipt of sBLA approval, the clinical and biomarker benefits could be continued through the use of a monthly dosing regimen which would be less burdensome and simpler to maintain long-term.
Eisai commenced the rolling submission of a BLA with the FDA seeing approval for the use of LEQEMBI subcutaneous autoinjector for weekly maintenance dosing after it received fast track designation from the regulator last month.
LEQEMBI is indicated for use in the US, China, Japan, and South Korea with applications being reviewed in the European Union, Brazil, Australia, Canada, Hong Kong and Great Britain among others.
Eisai is spearheading the activities associated with the development and regulatory submissions of lecanemab across the globe.
The company along with Biogen is jointly commercialising and promoting the asset while Eisai holds the final decision-making power.