FDA Approves Amgen’s Uplizna as First Treatment for IgG4-Related Disease, Achieving 87% Reduction in Flare Risk” ###

FDA Approval:
Uplizna (inebilizumab-cdon) by Amgen is now the first and only FDA-approved treatment for adults with IgG4-related disease (IgG4-RD), a chronic immune-mediated fibroinflammatory disease2 4 8.

Efficacy:
Uplizna achieved an 87% reduction in the risk of IgG4-RD flares compared to placebo in the Phase 3 MITIGATE trial, which enrolled 135 patients across 22 countries1 5 8.

Mechanism of Action:
Uplizna is a monoclonal antibody targeting CD19+ B cells, including plasmablasts and plasma cells, which play a central role in the disease's pathophysiology. Despite its efficacy, the exact therapeutic mechanism in IgG4-RD remains unknown2 6 8.

Trial Findings: Key outcomes included:

A significantly lower annualized flare rate.
Increased rates of flare-free, glucocorticoid-free remission at one year.
No new safety signals detected1 5 8.

Disease Background:
IgG4-RD is a rare, systemic disease causing fibrosis and inflammation across multiple organs, with symptoms often mimicking other diseases. It disproportionately affects older adults and more often affects men than women2 7 9.

Impact:
This approval addresses a major unmet need, offering a targeted and steroid-sparing alternative to standard glucocorticoid therapy, which often carries harmful side effects2 6 8.

Administration:
The drug is administered via intravenous infusion only twice a year after initial doses, adding convenience for patients2 6.

Broader Applications:
In addition to IgG4-RD, Uplizna is already FDA-approved for neuromyelitis optica spectrum disorder (NMOSD) and carries potential for expanded use in other immune-mediated diseases like myasthenia gravis6 8.

This milestone FDA approval signifies a significant advance for patients with IgG4-RD, providing a targeted therapy after decades of limited treatment options.