argenx Announces 2021 Corporate Priorities and Highlights Recent Achievements Across Immunology Pipeline - Seite 2

2021 Corporate Priorities and Recent Progress

The Company will continue its transition to a fully integrated immunology company by executing on three corporate priorities in 2021, including: preparation for the potential FDA approval and U.S. commercial launch of efgartigimod for the treatment of patients with gMG; the progression of its clinical-stage autoimmune pipeline; and the continued growth of its broad and differentiated pipeline through its Immunology Innovation Program.  

1. Preparation for potential FDA approval and global commercial launch of efgartigimod for the treatment of patients with gMG
    
   • Submitted BLA to FDA for efgartigimod for treatment of gMG and continued preparations for other global regulatory submissions
     • On track to submit application to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in first half of 2021
     • On track to submit to European Medicines Agency (EMA) in second half of 2021
     • Submission in China expected to occur shortly following potential approval in U.S.
        
   • Initiated bridging study for SC efgartigimod in gMG based on association between total IgG reduction and clinical benefit, and feedback from the FDA. The study is a registrational, non-inferiority trial comparing the pharmacodynamic effect of 1000mg SC efgartigimod with 10mg/kg IV efgartigimod and is expected to enroll approximately 50 patients.
      
   • Commercial preparation activities are underway and on track for potential 2021 launch, including continued engagement with key stakeholders, commercial inventory build, milestone-based hiring of field force around potential BLA acceptance and FDA approval, and development of a patient services program.
      
   • Appointed Anant Murthy, Ph.D., as General Manager of argenx Europe. In this role, Dr. Murthy will establish the commercial infrastructure for a European launch and lead market development activities in advance of a potential European Medicines Agency (EMA) approval of efgartigimod. Dr. Murthy brings ~20 years of international experience to argenx, most recently as Head of Market Access for EMEA and Canada and the General Manager of multiple European countries for Alnylam Pharmaceuticals.