Shots:
- The US FDA has approved the label expansion of argenx‘s Vyvgart (efgartigimod alfa-fcab) & Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) for the treatment of adult pts with gMG, expanding its use in all serotypes of gMG
- Approval was based on the P-III (ADAPT SERON) study assessing efgartigimod vs PBO in gMG pts (n=119) who do not have detectable anti-AChR-Ab across 3 serotypes: anti-MuSK-Ab+, anti-LRP4-Ab+, & triple seronegative
- Trial met its 1EP, showing a significant 3.35-point MG-ADL improvement at Wk. 4 vs PBO overall, with clinically meaningful benefits in MG-ADL & QMG scores across across subsequent treatment cycles in the overall population & in all serotypes
Ref: argenx | Image: argenx | Press Release
Related News: argenx Reports Topline P-III (ADAPT OCULUS) Trial Data on Vyvgart in Ocular Myasthenia Gravis (MG)
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