The US FDA has accepted the BLA under the accelerated approval for lecanemab to treat MCI due to AD & mild AD with confirmed presence of amyloid pathology in the brain. The PDUFA action date for Eisai’s application which was finished in early May 2022 is Jan 6, 2023
The P-III (Clarity AD) trial for lecanemab in early AD is ongoing in 1795 patients with expected results in 2022. The company plans to file for manufacturing & marketing approval of lecanemab in the US, Japan & EU at an end of Q1’23, based on the (Clarity AD) trial results
Lecanemab has received BTD & FTD from the FDA & is being evaluated in the P-III study for symptomatic early AD. Upon an acceptance of BLA by the US FDA, BioArctic receive a $15.83M milestone
Ref: PRNewswire | Image: BioArctic
