Interim Report for the period January – March 2023
Applications for market approval of lecanemab submitted on three continents Events during the first quarter 2023 · On January 6, the FDA approved lecanemab (Leqembi™) via the accelerated approval pathway for the treatment of Alzheimer's disease · BioArctic’s partner Eisai has filed for full approval for lecanemab in the US, EU, Japan and China. The submissions have all been accepted for review with the ones in the US, Japan and China being granted priority review · The Prescription Drug User Fee Act (PDUFA) action date for full approval in the US is July 6, 2023 · The