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News

argenx Reports the US FDA’s Approval of Vyvgart Hytrulo Prefilled Syringe for gMG and CIDP

Shots:

  • The US FDA has approved Vyvgart Hytrulo (efgartigimod alfa & hyaluronidase-qvfc) prefilled syringe to treat AChR+ adults with generalized myasthenia gravis (gMG) & adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
  • Approval was based on studies showing bioequivalence to Vyvgart Hytrulo vial, with human factors validation confirming that pts with gMG or CIDP, or their caregivers, could safely & successfully administer the prefilled syringe formulation
  • Vyvgart Hytrulo prefilled syringe, developed with Halozyme’s Enhanze technology, allows 20 to 30 sec subcutaneous self-injection by pts, caregivers, or healthcare professionals after proper training

Ref: argenx  | Image: argenx 

Related News:- argenx and Zai Lab Report the NMPA’s Approval of Vyvgart Hytrulo for Chronic Inflammatory Demyelinating Polyneuropathy

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