Amgen’s Uplizna first FDA-approved drug for Ig4A-RD

4 April 2025

The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), the drug’s developer, Amgen (Nasdaq: AMGN) announced yesterday.

IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy designation to Uplizna for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine’s potential to benefit patients, the US biotech giant noted..

The drug’s approval is expected to boost Amgen’s revenue, with Bloomberg projecting $516 million in sales by 2025.

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