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news.Octapharma USA has received approval from the US Food and Drug Administration (FDA) for its Octagam 10% to treat adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.
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Octagam 10% [immune globulin intravenous (human) 10% (100mg/ml) liquid preparation] helps in rapidly raising platelet counts to control or prevent bleeding in chronic ITP patients.
The FDA approval of Octagam 10% is based on data from an Octapharma-sponsored clinical trial that evaluated the safety and efficacy of Octagam10% in 66 chronic ITP patients aged between 17 and 88 years.
During the clinical trial, headache, fever and increased heart rate were the most common treatment-related adverse events observed with Octagam 10% treatment.
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," Nielsen added.
"Octapharma looks forward to providing the product in the US, further advancing our vision of providing patients with therapies to treat life-threatening conditions."
Octagam 10%, an intravenous immunoglobulin 10% formulation, is a solvent/detergent treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma.
The company has been marketing Octagam 5% [immune globulin intravenous (human) 5% (50 mg/ml) liquid preparation] since 2004 for the treatment of primary humoral immunodeficiency.