argenx Secures FDA Clearance for VYVGART Prefilled Syringe in Myasthenia Gravis and CIDP

ARGENX ANNOUNCES FDA APPROVAL OF VYVGART HYTRULO PREFILLED SYRINGE FOR SELF-INJECTION IN GENERALIZED MYASTHENIA GRAVIS AND CHRONIC INFLAMMATORY DEMYELINATING POLYNEUROPATHY

Breda, the Netherlands – April 10, 2025 – Argenx SE, a clinical-stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has approved the VYVGART (efgartigimod) Hytrulo Prefilled Syringe for self-injection in patients with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). The approval marks a significant milestone for patients with these debilitating autoimmune diseases, as it provides a new treatment option for self-injection, offering greater flexibility and convenience in their treatment regimens.

The approval is based on the results of the Phase 3 LUMINEER study, which demonstrated the efficacy and safety of VYVGART in patients with gMG and CIDP. The study showed that VYVGART significantly improved patient outcomes, including improved quality of life, reduced symptom severity, and improved functional ability.

"We are thrilled to bring this new treatment option to patients with gMG and CIDP, who have been seeking more convenient and effective ways to manage their symptoms," said Dr. Tim Van Hauwermeiren, CEO of Argenx. "The approval of VYVGART Hytrulo Prefilled Syringe for self-injection marks a significant step forward in our mission to develop innovative therapies that improve the lives of patients with autoimmune diseases."

VYVGART is a humanized monoclonal antibody that targets the membrane attack complex (MAC), which is a key component of the complement system. The drug has shown promise in treating a range of autoimmune diseases, including gMG and CIDP.

The VYVGART Hytrulo Prefilled Syringe is designed for self-injection, allowing patients to administer the medication at home, as needed. This new treatment option offers greater flexibility and convenience in patients' treatment regimens, which can be particularly important for those with gMG and CIDP, who often require ongoing treatment to manage their symptoms.

About Argenx Argenx SE is a clinical-stage biotechnology company focused on developing innovative therapies for the treatment of autoimmune diseases. The company is headquartered in Breda, the Netherlands, and has operations in the United States and Europe. For more information, please visit www.argenx.com.