US biopharmaceutical company Amgen (NASDAQ:AMGN) announced on Thursday that the US Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD).

The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognising the high unmet medical need in this serious condition and the medicine's potential to benefit patients.

The approval of UPLIZNA for IgG4-RD is supported by data from the MITIGATE trial, the first randomised, double-blind, placebo-controlled trial conducted in IgG4-RD. This trial demonstrated the potential of UPLIZNA to decrease disease activity by reducing flares in patients, while maintaining its efficacy and established safety profile.

This is the second approved indication for UPLIZNA, which was previously approved by the FDA for the treatment of adult patients with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020. The FDA also granted UPLIZNA Orphan Drug Designation for the treatment of generalised myasthenia gravis (gMG). Regulatory filing activities are underway for gMG with submission anticipated to be complete in the first half of 2025.