argenx Reports Topline Results from ADVANCE-SC Study of VYVGART Hytrulo in Primary Immune Thrombocytopenia - Seite 2

Results from the first study in the ITP registrational program, ADVANCE-IV, were reported in May 2022. The study met its primary and key platelet-derived secondary endpoints. ADVANCE-IV formed the basis of the regulatory submission for approval of VYVGART IV for ITP in Japan, where a decision is expected in the first quarter of 2024.

VYVGART is currently being evaluated in 13 severe autoimmune diseases, including the registrational ADDRESS study for pemphigus from which topline results are expected around year-end 2023.

Conference Call Details
argenx will host a conference call today at 2:30 pm CET (8:30am ET) to discuss the ADVANCE-SC results. A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

Dial-in numbers:
Please dial in 15 minutes prior to the live call.

Belgium                32 800 50 201
France                        33 800 943355
Netherlands                31 20 795 1090
United Kingdom        44 800 358 0970
United States                 1 888 415 4250
Japan                        81 3 4578 9081
Switzerland                41 43 210 11 32

About the ADVANCE-SC Study

The ADVANCE-SC trial was a randomized, double-blind, placebo-controlled, multicenter, global trial evaluating the efficacy and safety of VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adult patients with chronic or persistent primary ITP. ​ Enrolled patients had a confirmed ITP diagnosis and a mean entry platelet count of less than 30x10⁹/L. Patients were on a stable dose of at least one ITP treatment prior to randomization and had received at least one prior therapy. Concomitant medications permitted included corticosteroids, nonsteroidal immunosuppressive drugs, fostamatinib or TPO-RAs. The study patients who were on 'watch and wait' at baseline were required to have received at least 2 prior treatments for ITP. ​