Celltrion's Aptozuma Receives Additional FDA Approval for Pediatric COVID-19 Indication in the U.S.

Celltrion's autoimmune disease treatment 'Aptozuma' (active ingredient: tocilizumab) has expanded its treatment scope in the United States to include pediatric COVID-19 patients.

On October 7, Celltrion announced that the intravenous (IV) formulation of Aptozuma received additional approval from the U.S. Food and Drug Administration (FDA) for use in pediatric COVID-19 patients aged two and older. As a result, the scope of COVID-19 treatment for Aptozuma has been expanded from adult patients to include pediatric and adolescent patients aged two years and older.

Aptozuma is a biosimilar of tocilizumab, which inhibits the action of interleukin (IL)-6, a key mediator of inflammatory response in the body. In the United States, Aptozuma is approved for indications such as rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), and COVID-19.

Celltrion obtained FDA approval for Aptozuma's subcutaneous (SC) and IV formulations in January last year. Subsequently, after receiving an additional indication for cytokine release syndrome (CRS) with the IV formulation, the company has now secured the pediatric COVID-19 indication, thereby expanding its range of approvals in the U.S.

In particular, as the IV formulation is administered in hospitals, prescription accessibility at general hospitals and specialized medical institutions is regarded as a key factor for market expansion. Through this additional indication, Celltrion plans to expand its prescription base to include pediatrics and emergency medicine and broaden the selection of formulations according to patients' conditions and treatment environments.

The original drug, 'Actemra', recorded global sales of approximately 2.47 billion Swiss francs (about KRW 3.7 trillion) last year. According to global pharmaceutical market research agency IQVIA, last year the U.S. tocilizumab market was estimated at around USD 1.978 billion (approximately KRW 2.7692 trillion).

A Celltrion official stated, "With the addition of the pediatric COVID-19 indication, we have broadened the treatment options for pediatric patients and strengthened Aptozuma's competitiveness in the U.S. tocilizumab market. We will continue to expand prescriptions and strengthen our market presence through close communication with medical professionals."

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