FDA Approves Octagam 10% for Immune Thrombocytopenic Purpura
Product expected to be available in September
The FDA has approved Octagam 10% (immune globulin intravenous [human] 10% [100 mg/mL] liquid preparation, Octapharma USA) for the treatment of adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.
Since 2004, Octagam 5% (immune globulin intravenous [human] 5% [50 mg/mL] liquid preparation) has been marketed for the treatment of primary humoral immunodeficiency.
Octagam 10% is expected to be available in the U.S. in September 2014.
The FDA’s approval was based on the results of a clinical trial that evaluated the safety and efficacy of Octagam 10% in 66 patients (aged 17 to 88 years) with chronic ITP.
The study — published in the October 2010 issue of Hematology — found that 82% of patients with chronic ITP had attained the primary efficacy endpoint of a clinical response (i.e., platelet count ≥ 50 × 109/L within 7 days of dosing), which was significantly higher than the predicted responder rate of 70%. There were no unexpected tolerability issues even at the maximum infusion rate of 0.12 mL/kg/minute (720 mg/kg/hour). Further, 78% of patients with chronic ITP who had bleeding at baseline reported no bleeding 7 days after treatment.
The most common treatment-related adverse events associated with Octagam 10% included headache, fever, and increased heart rate. The most serious adverse event was a moderate headache.
Octagam 10% is indicated for the treatment of chronic ITP in adults to rapidly increase platelet counts to control or prevent bleeding. Octagam 10% is a solvent/detergent-treated, sterile preparation of highly purified immunoglobulin G derived from large pools of human plasma. The product is a solution for infusion to be administered intravenously.
The labelling for Octagam 10% includes a boxed warning regarding the potential for thrombosis, renal dysfunction, and acute renal failure.