Argenx announces FDA approval of Vyvgart self-injection option

Argenx (ARGX) announced that the U.S. Food and Drug Administration approved a new option for patients to self-inject VYVGART Hytrulo with a prefilled syringe for the treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive and adult patients with chronic inflammatory demyelinating polyneuropathy. “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., Ph.D., Chief Medical Officer, argenx. “We understand patients experience MG and CIDP in different ways, and our prefilled syringe is an important innovation that provides patients with more freedom and flexibility to self-administer VYVGART Hytrulo. Whether patients prefer to receive their treatment in a physician’s office, at home, or while traveling, they can experience treatment on their own terms and continue to benefit from VYVGART Hytrulo’s favorable safety profile and strong efficacy.”