Zai Lab and argenx Report the NMPA’s Approval of Efgartigimod Alfa SC Injection to Treat Generalized Myasthenia Gravis
Shots:
- The NMPA has granted approval to efgartigimod alfa SC injection, 1000mg (5.6ml)/vial, as an add-on therapy for generalized myasthenia gravis adults positive to AChR antibody. Zai Lab holds exclusive rights to develop & commercialize it across Greater China as per an agreement with argenx
- Approval was based on a P-III (ADAPT-SC) bridging trial that reached the 1EP of noninferiority showing 66.4% vs 62.2% reduced mean total IgG with efgartigimod SC vs IV at D29 along with 2EPs depicting similar efficacy to ADAPT study
- The safety of efgartigimod SC aligned with the ADAPT study & was well-tolerated with the most frequent AE as mild to moderate injection site reactions that were resolved
Ref: Zai Lab | Image: Zai Lab
Related News:- argenx's Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Receives the US FDA’s Approval for Generalized Myasthenia Gravis
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
