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Amgen’s Rare Disease Portfolio Grows With Second Approved Uplizna Indication

Generalized Myasthenia Gravis Could Be Third

 
• By Mandy Jackson

The US FDA approved anti-CD19 antibody Uplizna, from Amgen’s $27.8bn purchase of Horizon in 2023, for IgG4-related disease – a larger market than its original NMOSD indication.

Uplizna's approval in IgG4-RD adds to the rare disease foundation Amgen built with its Horizon acquisition (Shutterstock)
Key Takeaways
  • Amgen won US FDA approval for anti-CD19 antibody Uplizna (inebilizumab) in IgG4-related disease – the first-ever drug approved for the fibroinflammatory condition, which can affect multiple organs.
  • This is the second indication for Uplizna, which came from the $27.8bn purchase of Horizon that laid the foundation for Amgen’s rare disease portfolio, and the company built a new sales team for launch.
  • While near-term competition in IgG4-RD is limited, Amgen will file Uplizna for approval to treat generalized myasthenia gravis – a more competitive indication – during the first half of 2025.

Nearly five years after its first approval for neuromyelitis optica spectrum disorder (NMOSD) in June 2020, the US Food and Drug Administration approved Amgen’s Uplizna (inebilizumab) to treat adults with immunoglobulin G4-related disease (IgG4-RD). The company, which bought the CD19-positive B-cell-depleting antibody in its $27

Amgen reported positive Phase III results for the drug in March in the treatment of

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