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.
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.
"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.
