On August 7, 2025, Celltrion announced that it obtained FDA approval expanding the indication of the intravenous (IV) formulation of AVTOZMA (tocilizumab-anoh) to include treatment of cytokine release syndrome (CRS) in patients aged 2 years and older. CRS is a potentially life-threatening condition brought on by a so-called "cytokine storm" whereby the body's immune system becomes overactivated causing widespread inflammation and damage.
As we previously reported, Celltrion obtained FDA approval for AVTOZMA in January 2025 (and European Commission approval in February 2025) for various inflammatory conditions including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus disease.
With the approval of this new indication, AVTOZMA IV now covers each of the indications approved for Genentech's ACTEMRA IV. Thomas Nusbickel, Chief Commercial Officer at Celltrion USA commented that the expanded indication "marks an important step forward in our mission to deliver a safe and effective therapy for CRS."
Celltrion reported that following a patent settlement agreement with Genentech, AVTOZMA IV is expected to be available in the United States beginning August 31, 2025. Celltrion also reported that it holds a license to market the subcutaneous formulation of AVTOZMA in the United States beginning on the launch date.
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