Submission package based on positive data from the phase 3 ADAPT-SC study demonstrating non-inferiority of subcutaneous (sc) efgartigimod compared to intravenous VYVGART® (Efgartigimod alfa-fcab) based on the decrease in total immunoglobulin G (IgG) at Day 29
Amsterdamthe Netherlands – 09/21, 2022 – argenx SE ((Euronext &, NASDAQ:ARGX), a global immunology company dedicated to improving the lives of people living with serious autoimmune diseases, today announced it has filed a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for SC Efgartigimod (1000 mg Efgartigimod -PH20) known. for the treatment of generalized myasthenia gravis (gMG) in adult patients.
SC Efgartigimod is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), ENHANZE from Halozyme® Drug delivery technology. ENHANZE facilitates the subcutaneous injection of biologics typically given via an intravenous (IV) infusion.
“Our vision for the gMG program is to provide the broadest range of treatments for people living with this debilitating and often overlooked disease. Everyone experiences gMG differently, which is why we are excited about the opportunity to introduce multiple routes to meet patients’ needs, including route of administration and dosing schedule,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “The filing of this BLA is the latest milestone to recognize our commitment to the gMG patient community. We look forward to working closely with the agency on the BLA review process and potentially producing another best-in-class option for gMG patients.”
The BLA submission package includes data from the Phase 3 ADAPT-SC study, which evaluated the non-inferiority of the pharmacodynamic (PD) effect of SC efgartigimod compared to intravenous VYVGART in adult patients with gMG. The majority of the included patients were positive for the acetylcholine receptor …
