FDA Approves Expanded Indication for Celltrion’s AVTOZMA

The U.S. Food and Drug Administration (FDA) has approved an expanded indication of the intravenous (IV) formulation of Celltrion’s AVTOZMA (tocilizumab-anoh) to include the treatment of cytokine release syndrome (CRS) in adults and pediatric patients aged 2 years and older.

Following FDA approval of the additional indication for CRS, AVTOZMA IV now aligns with all indications approved for ACTEMRA IV in the United States.

“We are proud that AVTOZMA IV has now achieved full indication alignment with the reference ACTEMRA IV. This milestone marks an important step forward in our mission to deliver a safe and effective therapy for CRS,” said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. “This FDA approval expands access to high-quality biologics and supports beneficial patient outcomes across multiple therapeutic areas.”