Zai Lab : Efgartigimod Alfa Injection Approved In China For Generalized Myasthenia Gravis

(RTTNews) - Zai Lab Limited (ZLAB) and argenx (ARGX) announced that China's National Medical Products Administration or NMPA approved the Biologics License Application or BLA for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis or gMG who are anti-acetylcholine receptor (AChR) antibody positive.

The BLA approval was supported by positive results from the global Phase 3 ADAPT-SC study, a bridging study to the Phase 3 ADAPT study, which formed the basis for approval of intravenous VYVGART in adult gMG patients.

Efgartigimod SC is also being evaluated for the potential treatment of additional autoimmune disorders. In May 2024, the NMPA accepted a supplemental Biologics License Application with priority review for efgartigimod SC in chronic inflammatory demyelinating polyneuropathy (CIDP). The U.S. Food and Drug Administration approved efgartigimod SC in June 2024 for adults with CIDP.

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