Celltrion's 온라인 바카라 사이트 IV receives additional U.S. FDA approval for CRS indication

[by Lee, Young Sung] Celltrion announced on August 7 that the intravenous (IV) formulation of its autoimmune disease treatment, 온라인 바카라 사이트 (tocilizumab), has received additional approval from the U.S. Food and Drug Administration (FDA) for the indication of cytokine release syndrome (CRS).

CRS is a severe systemic inflammatory response that can arise during immunotherapeutic interventions, such as CAR-T cell therapy. It is triggered by excessive immune activation, leading to a rapid increase in blood cytokine concentration levels. Previously, this indication was approved solely for the intravenous (IV) formulation of the original drug. Consistently, this recent FDA approval is restricted to the 온라인 바카라 사이트 IV formulation.

In January of this year, Celltrion received FDA approval for both the subcutaneous (SC) and intravenous (IV) formulations of 온라인 바카라 사이트. With the recent addition of the CRS indication for the IV formulation, 온라인 바카라 사이트 IV now holds the same full-label approval as the original drug in the United States. This includes indications for rheumatoid arthritis (RA), giant cell arteritis (GCA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and COVID-19.

The original drug of 온라인 바카라 사이트, Actemra, is an interleukin inhibitor that exerts its anti-inflammatory effects by inhibiting the interleukin (IL)-6 protein, a cytokine involved in the inflammatory response. In 2024, Actemra generated around CHF 2.645 billion (approximately USD 3.2 million) in global sales. Notably, the U.S. market alone accounted for more than half of its revenue, with sales reaching USD 1.862 billion.

Following 온라인 바카라 사이트 approval in Korea in late 2024, Celltrion has accelerated its global market entry by securing regulatory approvals in the U.S. and Europe earlier this year. Leveraging this momentum, the company aims to strengthen its product portfolio in the rapidly growing autoimmune disease market. Furthermore, Celltrion plans to broaden its therapeutic scope to include bone and ophthalmic diseases, thereby enhancing product synergies in major global markets, particularly in Europe and the United States.

"With this approval, 온라인 바카라 사이트 IV formulations is now authorized to be prescribed for all indications in the United States. This expanded therapeutic scope is anticipated to boost product competitiveness and increase its market share,” a Celltrion official stated. “As we prepare for the full-scale launch of 온라인 바카라 사이트 in key markets, including the U.S., in the second half of the year, we will conduct a thorough analysis of each market’s characteristics and focus on facilitating the product's rapid adoption."