Celltrion's Avtozma IV Formulation Receives Additional FDA Approval for CRS Indication in the U.S.

Securing Full Label Approval for IV Formulation in the U.S.
Expansion of Treatment Scope

Celltrion announced on August 7 that the intravenous (IV) formulation of its autoimmune disease treatment 'Avtozma' (ingredient name: tocilizumab) has received an additional indication approval from the U.S. Food and Drug Administration (FDA) for Cytokine Release Syndrome (CRS).

CRS is a severe systemic inflammatory response that can occur during immune cell therapies such as CAR-T treatment, and is characterized by a rapid increase in blood cytokine levels due to excessive immune activation. This indication has only been approved for the IV formulation even for the original drug, and this latest approval also applies solely to the IV formulation of Avtozma.

In January of this year, Celltrion received FDA approval for both the subcutaneous (SC) and intravenous (IV) formulations of Avtozma. With the additional approval of the CRS indication for the IV formulation, Avtozma IV now holds the same full label as the original drug in the U.S., covering all indications including rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), COVID-19, and CRS.

The original drug for Avtozma, Actemra, is an interleukin inhibitor that reduces inflammation by blocking the interleukin (IL)-6 protein involved in triggering inflammation in the body. Last year, Actemra recorded global sales of approximately 2.645 billion Swiss francs (about 4.0465 trillion KRW), with more than half of the revenue?1.862 billion U.S. dollars (about 2.6068 trillion KRW)?coming from the U.S. market alone.

Following domestic approval of Avtozma at the end of last year, Celltrion has also received product approvals in the U.S. and Europe early this year, accelerating its preparations to enter the global market. Based on this, the company plans to further strengthen its product lineup in the rapidly growing autoimmune disease market, while significantly expanding its therapeutic areas to include bone diseases and ophthalmic diseases, thereby enhancing synergy between products in major global markets such as Europe and the U.S.

A Celltrion official stated, "With this approval, Avtozma IV can now be prescribed for all indications in the U.S., which is expected to enhance product competitiveness and expand market share by broadening its treatment scope. As we prepare for the full-scale launch of Avtozma in major markets including the U.S. in the second half of the year, we will thoroughly analyze the characteristics of each market and do our utmost to ensure the product is established early."

This content was produced with the assistance of AI translation services.