IgG4-related disease first approved therapy FDA approval with anti-CD38 antibody rare disease treatment
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Takeda Receives FDA Approval for Mezagitamab in IgG4-Related Disease

Takeda announces FDA approval of mezagitamab for adults with IgG4-related disease, the first approved therapy for this rare fibroinflammatory condition.

Takeda today announced that the FDA has approved mezagitamab for the treatment of adults with IgG4-related disease (IgG4-RD). This marks the first therapy approved for IgG4-RD, a rare fibroinflammatory condition that can affect multiple organs including the pancreas, kidneys, and salivary glands. In the Phase 2 IGNITE trial, mezagitamab demonstrated a statistically significant reduction in IgG4-RD Responder Index score compared to placebo. Mezagitamab is an anti-CD38 antibody that depletes plasmablasts and plasma cells driving IgG4-RD.

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