Zai Lab Limited (ZLAB) and argenx (ARGX) have announced that China's National Medical Products Administration (NMPA) has approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection), at a dosage of 1,000mg (5.6ml)/vial. This treatment is intended as an adjunct to standard therapy for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
The approval of the BLA was underpinned by positive outcomes from the global Phase 3 ADAPT-SC study, which serves as a complement to the Phase 3 ADAPT study. The latter was the basis for the approval of the intravenous formulation of VYVGART in adult gMG patients.
Currently, efgartigimod SC is also being assessed for its potential in treating other autoimmune disorders. Notably, in May 2024, the NMPA accepted a supplemental Biologics License Application with priority review for efgartigimod SC as a treatment for chronic inflammatory demyelinating polyneuropathy (CIDP). Additionally, the U.S. Food and Drug Administration granted approval for efgartigimod SC for adults with CIDP in June 2024.
