Takeda Receives FDA Approval for Mezagitamab in Immune Thrombocytopenia

Takeda today announced that the FDA has approved mezagitamab for the treatment of adults with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. In the Phase 3 ADVANCE IV trial, mezagitamab demonstrated a statistically significant improvement in sustained platelet response compared to placebo. Mezagitamab is an anti-CD38 antibody that depletes antibody-producing plasma cells responsible for generating anti-platelet antibodies in ITP. This approval provides patients with a new treatment option for this chronic blood disorder.