Posted by Michael Wonder on 11 Jul 2023
Zai Lab announces acceptance by China’s NMPA of the BLA for efgartigimod alfa injection (subcutaneous injection) for patients with generalised myasthenia gravis
10 July 2023 - Zai Lab today announced that China’s NMPA has accepted the biologics license application for efgartigimod alfa for the treatment of adult patients with generalised myasthenia gravis.
The biologics license application submission is supported by positive results from the global Phase 3 ADAPT-SC trial, demonstrating non-inferior total IgG reduction from baseline at day 29 with subcutaneous administered efgartigimod compared to intravenous administered efgartigimod in adult patients with generalised myasthenia gravis
