argenx Announces Validation of European Marketing Authorization Application for Efgartigimod in Generalized Myasthenia Gravis
Validation initiates formal evaluation of application which started on August 19, 2021; decision expected mid-2022
If approved, efgartigimod will be the first-and-only approved FcRn antagonist in Europe
Regulatory reviews of efgartigimod for generalized myasthenia gravis currently underway in the U.S., Japan and Europe
Breda, the Netherlands – August 25, 2021 – argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced that it has submitted, and the European Medicines Agency (EMA) has validated, the marketing authorization application (MAA) for the Company’s investigational FcRn antagonist, efgartigimod, for the treatment of generalized myasthenia gravis (gMG). Validation of the MAA confirms that the application is sufficiently complete to begin the formal review process.
The MAA is supported by results from the pivotal Phase 3 ADAPT trial evaluating the safety and efficacy of efgartigimod for the treatment of patients with gMG.
“gMG is a severe, chronic and debilitating disease that can be unpredictable and greatly impact a person’s quality of life. The EMA’s validation is an exciting step closer to our goal of helping people globally who are living with this disease in which there remains a significant unmet need.” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “We have been building an experienced commercial team in Europe and look forward to our continued collaboration with European regulatory authorities through the review process.”
“There remains a significant unmet need for new gMG treatment options that are targeted to the underlying pathogenesis of the disease and supported by clinical data,” commented Prof. Dr. Andreas Meisel, Senior Physician of Neurology, Head of Myasthenia Gravis Outpatient Clinic at the Department of Neurology, Charité – Universitätsmedizin Berlin, and Principal Investigator on the ADAPT study. “Myasthenia gravis can severely impact a person’s quality of life and ability to carry out daily tasks, such as speaking, chewing and swallowing food, or brushing teeth and hair. In some cases, patients may also experience difficulty breathing. I am hopeful for continued research advancements for new options to treat this debilitating disease.”
Efgartigimod is currently under review with the U.S. Food and Drug Administration (FDA) for the treatment of gMG with a Prescription Drug User Fee Act (PDUFA) target action date of December 17, 2021. argenx also submitted and was notified of acceptance of an application for efgartigimod to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year.