argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Receives the US FDA’s Approval for Generalized Myasthenia Gravis
Shots:
- Halozyme reported that argenx received the US FDA’s approval of Vyvgart Hytrulo with Enhanze as SC use for gMG in adult patients who are AChR+. The product is expected to be available in the US in July 2023
- The approval was based on the P-III study (ADAPT-SC) evaluating Vyvgart Hytrulo vs Vyvgart (IV). The 1EPs of noninferiority were met & showed a mean total IgG reduction from baseline @29 Day (66.4% vs 62.2%) & the key 2EPs were met which were consistent with efficacy measures from the (ADAPT) study. The results were consistent with the (ADAPT) clinical trial
- The new SC formulation can be administered as a single inj. (1008mg fixed dose) by a healthcare professional. The MAA for efgartigimod (SC) is under EMA & PMDA review with an expected decision at the end of 2023 & Q1’24, respectively
Ref: PRNewswire | Image: argenx
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