argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease

ADHERE data show VYVGART Hytrulo has potential to be first advancement for CIDP patients in 30 years

Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART treatment

April 16, 2024 – 7:00am CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that data from its Phase 3 ADHERE trial evaluating VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) were presented for the first time to the medical community during the Clinical Trials Plenary Session at the American Academy of Neurology (AAN) Annual Meeting in Denver, CO.

argenx also highlighted clinical trial and real-world data across seven posters and presentations that continue to reinforce VYVGART and VYVGART Hytrulo as a transformative treatment option for gMG patients.

“Our innovative approach to autoimmunity research is changing expectations for the global immunology community,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The gMG and CIDP data presented at AAN reinforce that our pioneering approach to transforming autoimmunity is redefining what is possible for patients and their communities.”

“Patients with CIDP face a number of diagnostic and treatment challenges” said Jeffrey Allen, M.D., Professor, Department of Neurology, University of Minnesota and Principal Investigator in the ADHERE trial. “The results of the ADHERE trial show that VYVGART Hytrulo reduces the risk of clinical deterioration in patients with CIDP while minimizing side effects and reducing the treatment burden. These findings enhance our understanding of the role that IgG autoantibodies are likely to play in the disease, and open the door to new safe, effective and well-tolerated treatments that eliminate pathogenic IgGs.”

ADHERE Plenary Session (PL5) Highlights Rapid, Deep and Clinically Meaningful, and Durable Functional Improvements in CIDP

In the ADHERE study, a majority of patients treated with VYVGART Hytrulo, regardless of prior treatment, demonstrated evidence of rapid clinical improvement, and a reduced risk of relapse compared to those treated with placebo. As previously reported, ADHERE met its primary endpoint (p=0.000039) demonstrating a 61% reduction (HR: 0.39 95% CI: 0.25; 0.61) in the risk of relapse versus placebo. VYVGART Hytrulo was well-tolerated, and the observed safety and tolerability profile was consistent with previous clinical trials.