Argenx announces fda approval of vyvgart hytrulo prefilled syringe for self-injection in generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy

Vyvgart, the first-in-class fcrn blocker, now offers three administration options, including self-injection with a prefilled syringe self-injection provides gmg and cidp patients with flexibility for when and where to receive treatment – at home, while ‘on the go' or in a healthcare setting approval reflects commitment to innovating the patient experience with individualized, safe and effective therapies april 10, 2025, 11:45 pm cet amsterdam, the netherlands – argenx se (euronext & nasdaq: argx), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that the u.s. food and drug administration (fda) approved a new option for patients to self-inject vyvgart® hytrulo with a prefilled syringe (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gmg) who are anti-acetylcholine receptor (achr) antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy (cidp). “today's fda approval provides a new self-injection option across both approved indications in the u.s. that is designed for patients who seek more independence with their treatment,” said luc truyen m.d.
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