Shots:
The approval was based on the results from the P-III (ADAPT) trial evaluating the safety & efficacy of Vyvgart (efgartigimod alfa-fcab) vs. PBO in a ratio (1:1) for 26wks. in patients (n=167) with gMG across North America, Europe & Japan
The results demonstrated the response of anti-AChR Ab positive gMG patients treated with Vyvgart on the MG-ADL scale (68% vs. 30%) & on the QMG scale (63% vs 14%) vs PBO
Vyvgart is a human IgGI Ab fragment that binds to the neonatal Fc receptor (FcRN) to reduce the circulating IgG autoantibodies. Vyvgart has previously been approved in the US & Japan for the treatment of gMG whereas argenx & Zai Lab have jointly planned to launch Vyvgart in Canada & China
Ref: Globe Newswire | Image: Argenx
