BioArctic Partner Eisai Report the Completion of Rolling Submission of BLA to the US FDA for Lecanemab (BAN2401) to Treat Early Alzheimer's Disease
- The BLA submission was based on a P-IIb study evaluating lecanemab (10mg/kg, q2w) in 856 patients with MCI due to AD with confirmed presence of amyloid pathology, results from the P-IIb OLE study in 180 patients & P-III (Clarity AD) study in 1795 patients. The BLA is being submitted under accelerated approval
- The P-IIb study showed a reduction in brain amyloid @18mos. & clinical decline, 80% achieved amyloid negative status by visual read, 9.9% rate of ARIA-E over 0.8% in PBO
- Upon completion & acceptance of the BLA by the US FDA, BioArctic to receive a $15.83M milestone. Eisai plans to file for manufacturing & marketing approval in the US, Japan & EU in Q1’23, based on (Clarity AD) results
Ref: PRNewswire | Image: BioArctic
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