argenx’s Vyvgart with Halozyme’s Enhanze Receives the EC’s Approval for the Treatment of Generalized Myasthenia Gravis
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- The approval was granted based on the results from the P-III (ADAPT-SC) clinical trial evaluating the PD effect of Vyvgart as an SC (1000mg efgartigimod-PH20) vs IV (10mg/kg) dose in patients (n=110) with gMG across North America, EU & Japan
- The study met its 1EP depicting a mean total IgG reduction of 66.4% from baseline vs 62.2%. The 2EPs of the trial were also met with 69.1% & 65.5% of SC-treated patients were responders on MG-ADL & QMG score
- argenx’s Vyvgart is designed with the combination of efgartigimod alfa + rHuPH20 & is co-formulated with Halozyme’s Enhanze drug delivery technology. Earlier, Vyvgart received the CHMP’s positive recommendation & was approved by the US FDA on Jun’23 for gMG
Ref: PR Newswire | Image: argenx
Related News:- argenx’s Vyvgart Receives Approval from Health Canada to Treat Generalized Myasthenia Gravis (gMG)
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Shivani is a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She covers news related to Product approvals, clinical trial results, and updates. She can be contacted at connect@pharmashots.com.
