FDA nod for expanded indication of Avtozma

6 August 2025

The US Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of South Korean firm Celltrion’ (Kosdaq: 068270) Avtozma (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged two years and older.

Following FDA approval of the additional indication for CRS, Avtozma IV now aligns with all indications approved for Roche’s (ROG: SIX) Actemra IV in the United States.1

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