argenx Data Highlight Evidence that VYVGART and VYVGART Hytrulo Drive Transformative Outcomes for Patients with Debilitating Autoimmune Disease - Seite 2

• Evidence of rapid onset and maintenance of clinical response: In the open-label Stage A of the ADHERE study, 67% of patients treated with VYVGART Hytrulo demonstrated evidence of clinical improvement (ECI), including 40% who had achieved ECI by the earliest possible measure at week 4. In Stage B, VYVGART Hytrulo-treated patients maintained a clinical response to treatment longer than those on placebo as evidenced by a statistically significant and clinically relevant reduction in risk of relapse. Results across both Stage A and B indicate IgG autoantibodies play a significant role in mediating the underlying biology of CIDP.
  
  
• Deep and clinically meaningful functional improvements: 81% of VYVGART Hytrulo-treated patients demonstrated ≥1 point improvement on the aINCAT as compared to baseline Stage A scores in ADHERE, which includes 42% of patients with ≥2 point improvement, 28% with ≥3 point improvement, and 12% with ≥4 point improvement.
  
  
• Clinical benefit demonstrated regardless of prior CIDP treatment: Clinical benefit was seen across all patient subtypes, including those who had previously received corticosteroids, intravenous or subcutaneous immunoglobulin, or were on no treatment prior to study entry.
  
  
• High rate of treatment continuation: 99% of eligible patients continued to the ADHERE-Plus open-label extension study.
  
  
• FDA decision on CIDP sBLA expected by June 21, 2024: Data from the ADHERE trial were submitted to the U.S. Food and Drug Administration (FDA) as part of a supplemental Biologics License Application (sBLA) for VYVGART Hytrulo for the treatment of CIDP. The application was accepted for Priority Review in February 2024 and has been granted a PDUFA target action date of June 21, 2024.
  
  

AAN presentations highlight rapid, deep, and sustained improvements in gMG with ability to reduce steroid burden

Clinical trial data and real-world evidence presented during AAN continue to highlight the differentiated efficacy and safety profile of VYVGART and VYVGART Hytrulo, driving rapid, deep, and sustained improvement across disease scales and with different dosing schedules, including the ability for patients to achieve minimal symptom expression (MSE).

• MSE results in ADAPT/ADAPT+: Poster Session 10
• ADAPT-SC+ interim results: Poster Session 10
• ADAPT-NXT interim results: Poster Session 10
• Cost-benefit analysis of efgartigimod to IVIG in Canada: Poster Session 4

Side effects from long-term steroid use continue to be a significant burden associated with autoimmune disease, reinforcing the importance of the favorable safety profile of VYVGART. New data presented in an oral presentation (Scientific Platform Session 38) during AAN characterize how VVYGART treatment can significantly reduce concomitant steroid use.