FDA Approves Uplizna for IgG4-RD Treatment

The FDA has approved Amgen's drug Uplizna as the first and only treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare inflammatory condition affecting multiple organs. This approval, supported by the MITIGATE trial results, showed a significant 87% reduction in disease-related flares and a high rate of remission, positioning Uplizna as a critical advancement in IgG4-RD treatment. The drug, which binds to the CD19 protein on B cells, addresses the underlying inflammation mechanism. Uplizna was previously approved for neuromyelitis optica spectrum disorder and is being explored for other autoimmune diseases. The drug's ability to reduce glucocorticoid use offers a safer alternative to steroids, which are typically used in managing IgG4-RD. This approval is expected to boost Amgen's market performance, with projected peak sales of $1.3 billion by 2030 for IgG4-RD alone.