• VYVGART and VYVGART Hytrulo are the first and only approved treatments for all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative
• Patients treated with VYVGART in the ADAPT SERON study experienced rapid, significant and sustained symptom improvements that continued with ongoing treatment
• Approval advances argenx’s commitment to address the unique needs of every MG patient, delivering the broadest MG label to date
  
  

argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced the U.S. Food and Drug Administration (FDA) approved a label expansion for VYVGART® (efgartigimod alfa-fcab) and VYVGART Hytrulo® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG). The approved supplemental Biologics License Application (sBLA) expands VYVGART’s indication to include all serotypes of adult patients living with gMG – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.

The approval is based on data from the Phase 3 ADAPT SERON study, the largest study to date of patients with gMG who do not have detectable anti-acetylcholine receptor antibodies (AChR-Ab) across three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The overall population of patients in the study treated with VYVGART showed rapid, significant and sustained improvements in their gMG symptoms, including speech, vision, physical function and swallowing, among others. In addition, VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.

“Today’s approval means that all adult gMG patients, regardless of serotype, can now benefit from VYVGART’s rapid onset, sustained disease control, and favorable safety profile,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. "For clinicians, this simplifies treatment decisions, representing a major advancement in reaching as many patients living with gMG as possible.”

“MG affects patients in various ways, and those with gMG who do not have detectable AChR antibodies need safe, effective treatments. Prior to the ADAPT SERON study, these patients were rarely included in clinical trials,” said James F. Howard Jr., M.D., Professor of Neurology (Neuromuscular Disease), Medicine and Allied Health, Department of Neurology, The University of North Carolina at Chapel Hill School of Medicine. “MG leads to debilitating muscle weakness, causing challenges with vision, movement, speech, swallowing, and even breathing. Although many MG patients have detectable AChR-Ab, roughly 20% do not, making diagnosis and management especially difficult. The expanded indication of efgartigimod for use in all adult gMG patients enables healthcare providers to prescribe this targeted treatment more readily upon clinical diagnosis, irrespective of serotype.”

Detailed results from the Phase 3 ADAPT SERON study:

• Patients showed clinically meaningful improvements in disease activity across all three serotypes – anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
• The primary endpoint was met (p=0.0068), demonstrating that patients treated with VYVGART achieved a statistically significant improvement in MG-ADL (Myasthenia Gravis Activities of Daily Living) total score compared to placebo at week 4.
• In the overall population – across all serotypes in the study – mean change from baseline in patients treated with VYVGART was a clinically meaningful 3.35-point improvement in MG-ADL total score at week 4.
• Improvements in MG-ADL and Quantitative Myasthenia Gravis (QMG) scores were observed across subsequent treatment cycles in the overall population and in all serotypes studied.
• VYVGART was well tolerated across serotypes, with safety consistent with the established profile in patients with anti-AChR-Ab positive gMG.
  
  

“For too long, gMG patients who do not have detectable AChR-Ab have been left behind, feeling disengaged and excluded from receiving treatments that specifically treat their disease, which has led to patients experiencing a higher burden of suffering,” said Allison Foss, Executive Director of the Myasthenia Gravis Association. “This approval validates that gMG patients without AChR-Ab can benefit from a targeted treatment, bringing a sense of hope to thousands in our community.”

argenx recently announced positive top-line results from the ADAPT OCULUS study of VYVGART Hytrulo in ocular MG and remains focused on advancing the development of VYVGART for all patients living with MG, including pediatric gMG patient populations in the ADAPT Jr study.

VYVGART is available to patients in three administration options, including VYVGART Hytrulo self-injection with a prefilled syringe.