Halozyme Announces FDA Approval of argenx's VYVGART® Hytrulo Prefilled Syringe Co-Formulated with ENHANZE® for Self-Injection for Generalized Myasthenia Gravis and Chronic Inflammatory Demyelinating Polyneuropathy

Core Insights - Halozyme Therapeutics, Inc. announced that argenx received FDA approval for VYVGART® Hytrulo prefilled syringe for self-injection, targeting adult patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) [1][2] Group 1: Product Details - VYVGART® Hytrulo is designed for a 20-to-30-second subcutaneous injection, allowing self-administration by patients or caregivers after proper training [2] - The approval is based on studies demonstrating bioequivalence to the vial version of VYVGART® and successful administration by participants in human factors validation studies [2] Group 2: Company Overview - Halozyme is a biopharmaceutical company focused on improving patient experiences through its ENHANZE® drug delivery technology, which facilitates rapid subcutaneous delivery of biologics [3] - The company has impacted over one million patients globally through its technology, which is licensed to major pharmaceutical companies including Roche, Takeda, and Pfizer [3] Group 3: Additional Products and Technologies - Halozyme also develops drug-device combination products using advanced auto-injector technologies aimed at enhancing patient comfort and adherence [4] - The company has two proprietary commercial products, Hylenex® and XYOSTED®, and is engaged in ongoing development with partners like Teva Pharmaceuticals [4]