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BioArctic Partner Eisai Report the Completion of Rolling Submission of BLA to the US FDA for Lecanemab (BAN2401) to Treat Early Alzheimer's Disease

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BioArctic Partner Eisai Report the Completion of Rolling Submission of BLA to the US FDA for Lecanemab (BAN2401) to Treat Early Alzheimer's Disease

BioArctic Partner Eisai Report the Completion of Rolling Submission of BLA to the US FDA for Lecanemab (BAN2401) to Treat Early Alzheimer's Disease

Shots:

  • 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

Click here to­ read the full press release 

Neha

Neha Madan is a content writer at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots.

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