ARGX - argenx Delivers on Promise to Transform Patient Expectations in Autoimmunity at American Academy of Neurology 2024 Annual Meeting | Benzinga

ADHERE data presentation will highlight first potential innovation for CIDP patients in 30 years

Abstracts reflect real-world value and consistent efficacy and safety profile associated with long-term use of VYVGART® and VYVGART® Hytrulo in gMG patients

March 7, 2024, 10:01 pm CET

Amsterdam, the Netherlands   – argenx SE ((Euronext &amp, NASDAQ:ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that eight abstracts, including two oral presentations, featuring clinical trial and real-world data for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in rare autoimmune diseases will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, CO from April 13-18, 2024.

"We are opening a new chapter for the VYVGART portfolio," said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "While VYVGART continues to reach more gMG patients globally, we are also striving to bring meaningful benefits to people living with CIDP – a community which has been awaiting innovation for 30 years. We are excited to present a broad set of data at AAN this year that collectively demonstrate how we are delivering on our promise to transform patients' lives with innovative treatments."  

Transforming Autoimmunity by Targeting FcRn

Findings from the ADHERE study of VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) will be presented for the first time in an oral presentation during the Clinical Trials Plenary Session, taking place on Tuesday, April 16, 2024. These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024.

In addition to the full ADHERE data, the AAN presentations will highlight clinical trial and real-world data showcasing the broad opportunity with VYVGART, a first-in-class neonatal FC receptor (FcRn) inhibitor, and VYVGART Hytrulo, to deliver significant value to the generalized myasthenia gravis (gMG) patient community by driving consistent and repeatable improvements across patient subtypes, a favorable and predictable safety profile, and the ability to individualize treatment across both intravenous and subcutaneous administration and dosing schedules.

• Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies. Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment.
  
  
• Favorable safety profile across IgG-mediated autoimmune diseases: A review of safety findings across multiple studies of VYVGART in IgG-mediated autoimmune diseases showed VYVGART was consistently well tolerated across all indications and doses studied.
  
  
• ADAPT NXT evaluated additional individualized dosing regimens for initiating long-term treatment: Data from the Phase 3b ADAPT NXT study will provide important guidance on different treatment regimens, which will allow for additional individualization of VYVGART treatment.
  
  
• Potential for tapering of oral corticosteroids (OCS) post-VYVGART initiation: Long-term OCS use continues to be a significant burden on people living with autoimmune disease and reducing or tapering OCS may alleviate the risk of many adverse events related to long-term usage. Early insights into OCS utilization post-efgartigimod initiation in gMG patients indicate that a substantial proportion reduced OCS usage over the first 6 months of treatment.
  
  
• Cost-effectiveness of VYVGART compared to chronic intravenous immunoglobulin (IVIg): Findings from a cost-effectiveness analysis of VYVGART versus chronic IVIg for the treatment of gMG showed that, over a lifetime, VYVGART provided greater benefit at lowers costs.
  
  

Details for oral and poster presentations at AAN are as follows:

Full story available on Benzinga.com