Zai Lab announces China NMPA acceptance of efgartigimod alfa injection BLA

Zai Lab announced that China’s National Medical Products Administration has accepted the Biologics License Application for efgartigimod alfa injection for the treatment of adult patients with generalized myasthenia gravis. The BLA submission is supported by positive results from the global Phase 3 ADAPT-SC study, demonstrating noninferior total IgG reduction from baseline at day 29 with SC administered efgartigimod compared to intravenous administered efgartigimod in adult patients with gMG. Patients treated with efgartigimod SC achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with efgartigimod IV. The safety profile for efgartigimod SC was also consistent with the ADAPT study. It was generally well-tolerated; the most frequent adverse event being injection site reactions, commonly observed with biologics administered subcutaneously. All ISRs were mild to moderate and resolved over time.