Amgen Phase III Data Could Add Second Indication To Uplizna’s Label

 
• By Joseph Haas

Amgen’s study shows an 87% risk-reduction for IgG4-related disease flares, which can exacerbate the rare disorder and lead to irreversible organ failure. A US filing is planned.

Rare disease
Amgen's hopes Uplizna can become the first approved therapy for IgG4-RD • Source: Shutterstock

Amgen, Inc. could more than double the patient base for Uplizna (inebilizumab), currently approved to treat neuromyelitis optica spectrum disorder (NMOSD), with new Phase III data showing the antibody therapy can also treat patients with the rare immune-mediated disease immunoglobulin G4-related disease (IgG4-RD).

Key Takeaways

  • Uplizna may become the first approved therapy for IgG4-related disease after hitting its primary and three secondary endpoints in Phase III

In the Phase III MITIGATE study, released 5 June, Uplizna reduced disease-related flares by 87% compared to placebo in the...

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