argenx SE (Euronext & Nasdaq: ARGX) and Zai Lab Limited (Nasdaq: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for VYVGART® (efgartigimod alfa injection), a first-in-class neonatal Fc receptor (FcRn) antagonist, as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Zai Lab will now work with the National Healthcare Security Administration (NHSA) for NRDL inclusion to enable broad access for patients.
“This approval by the NMPA for VYVGART, our sixth approval globally, is the first-and-only FcRn blocker available for people living with gMG in China. This is another milestone on our path to redefine what well-controlled means for gMG patients and underscores our longstanding commitment to the global gMG community,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We celebrate this achievement with our partner, Zai Lab, who shares our mutual passion to bring needed innovation to people with gMG in China. We look forward to continuing our partnership as we further explore efgartigimod in other indications, expanding our global footprint in one of the world’s fastest growing markets to reach more people living with severe autoimmune diseases.”
“We are pleased to have the NMPA’s approval for VYVGART for intravenous use. This important milestone brings forward a novel treatment for gMG patients who face many challenges living with this complex and difficult-to-control autoimmune disease,” said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. “We appreciate the NMPA for their thorough assessment of VYVGART, recognizing its differentiated profile and the large unmet medical need in China. In addition to gMG, we are working with argenx on three registrational programs exploring other immunoglobulin G (IgG)-related autoimmune indications and are looking forward to exploring even more indications over time.”
“There are over 200,000 people living with myasthenia gravis (MG) in China1. Despite the availability of current treatment options, there remains a significant unmet medical need. The approval of VYVGART in China marks an important milestone for patients and provides physicians with a novel, safe and effective therapy to help improve the quality of life for those in their care,” said Dr. Chongbo Zhao, M.D., Ph.D., Deputy Director of Department of Neurology, Huashan Hospital Affiliated to Fudan University, Director of Working Group of Huashan Rare Disease Center. “In clinical studies, efgartigimod demonstrated outstanding characteristics in terms of onset of action, efficacy, and safety, helping to improve patients' muscle strength and quality of life. VYVGART, the first-and-only approved FcRn antagonist for gMG patients in China, has the potential to revolutionize the treatment landscape for gMG patients in China and we are grateful to Zai Lab for providing the support for these patients who have been devastated by this disease for so long.”
The global Phase 3 ADAPT trial met its primary endpoint, demonstrating that significantly more anti-AChR antibody positive gMG patients were responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale following treatment with efgartigimod compared with placebo (68% vs. 30%; p<0.0001). Responders were defined as having at least a two-point reduction on the MG-ADL scale sustained for four or more consecutive weeks during the first treatment cycle2.
There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with efgartigimod compared with placebo (63% vs. 14%; p<0.0001). Responders were defined as having at least a three-point reduction on the QMG scale sustained for four or more consecutive weeks during the first treatment cycle.
VYVGART demonstrated a well-tolerated safety profile in the ADAPT clinical trial. The most commonly reported adverse reactions that occurred more frequently with VYVGART than placebo were upper respiratory tract infections (10.7% following treatment with efgartigimod vs. 4.8% of placebo) and urinary tract infections (9.5% vs. 4.8%).