REG-argenx Announces U.S. FDA Approval Expanding VYVGART and VYVGART Hytrulo for Use in All Adult Patients Living with gMG
The FDA approved VYVGART and VYVGART Hytrulo for the treatment of all serotypes of adult patients with generalized myasthenia gravis (gMG). The approval is based on data from the Phase 3 ADAPT SERON study, which demonstrated rapid, significant, and sustained improvements in gMG symptoms across all serotypes. VYVGART and VYVGART Hytrulo are now available to a broader patient population, including those who are anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
Key figures
- Drug Name
- VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc)
- Phase Of Trial
- Phase 3
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