- In April 2025, Johnson & Johnson received FDA approval for IMAAVY (nipocalimab‑aahu), a first-in-class FcRn blocker for the treatment of generalized myasthenia gravis (gMG) in adults and adolescents aged 12 years and older. This marks the broadest patient indication in the FcRn class to date, covering both anti-AChR and anti-MuSK antibody-positive patients. The approval strengthens J&J’s leadership in neuroimmunology and expands its rare disease portfolio
- In June 2023, argenx received FDA approval for VYVGART Hytrulo, the first subcutaneous injectable FcRn blocker, for adult anti-AChR antibody-positive gMG patients. This advancement allows patients to self-administer treatment at home, providing more flexibility and convenience in disease management. The launch has accelerated the shift toward patient-centric biologics in neuromuscular care
- In October 2023, UCB secured FDA approval for ZILBRYSQ (zilucoplan), a once-daily subcutaneous peptide inhibitor of complement C5, for adult patients with anti-AChR antibody-positive gMG. ZILBRYSQ offers the first and only self-administered complement inhibitor, positioning UCB as a leading player in complement-mediated neuromuscular diseases
- In June 2023, UCB also received FDA approval for RYSTIGGO (rozanolixizumab-noli), an FcRn-blocking monoclonal antibody for both AChR and MuSK-positive gMG patients. Administered subcutaneously on a weekly basis, RYSTIGGO offers a targeted mechanism with broad coverage and contributes to personalized therapy strategies in gMG treatment
- In March 2024, Meiji Seika Pharma and its subsidiary Medicago announced their collaboration with Japanese neurology centers to expand access to investigational gMG biologics, focusing on precision therapy and biomarker-driven clinical trials. This initiative is expected to enhance treatment options for MuSK-positive and seronegative myasthenia gravis patients in Asia
