The US Food and Drug Administration (FDA) has approved Octapharma USA’s Octagam 10% for treatment of adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.
Octagam 10% [immune globulin intravenous (human) 10% (100mg/ml) liquid preparation] rapidly raises platelet counts to control or prevent bleeding in chronic ITP patients.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
US approval of Octagam 10% is supported by data from an Octapharma-sponsored clinical trial that assessed the safety and efficacy of Octagam10% in 66 chronic ITP patients aged between 17 and 88 years.
Headache, fever, and increased heart rate were the most common treatment-related adverse events observed with Octagam 10% treatment during the clinical trial.
The company is expected to launch Octagam 10% in the US in September.
Octapharma USA president Flemming Nielsen said: "The FDA approval of Octagam 10% represents a significant Octapharma milestone, but, more importantly, opens up new treatment options for patients.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData"Octagam 10% has demonstrated safety and efficacy in a pivotal clinical trial.
"Octapharma looks forward to providing the product in the US, further advancing our vision of providing patients with therapies to treat life-threatening conditions."
An intravenous immunoglobulin 10% formulation, Octagam 10% is a solvent/detergent treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.
Octapharma USA has been marketing Octagam 5% [immune globulin intravenous (human) 5% (50 mg/ml) liquid preparation] since 2004 for the treatment of primary humoral immunodeficiency.
