EMA Backs Amgen Drug For Rare Autoimmune Disorder

Benzinga
2025.09.19 17:17
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The European Medicines Agency (EMA) has recommended Amgen Inc.'s Uplizna (inebilizumab) for treating adult patients with active immunoglobulin G4-related disease (IgG4-RD), a rare autoimmune disorder. Currently, there are no authorized treatments for IgG4-RD in the EU. Uplizna, already approved for neuromyelitis optica spectrum disorders, showed significant efficacy in a phase 3 trial, with longer median time to flare and higher rates of corticosteroid-free remission compared to placebo. Following the news, Amgen's stock rose by 2.69% to $283.26.