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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.

Nearly five years after its first approval for neuromyelitis optica spectrum disorder (NMOSD) in June 2020, the US Food and...

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