Octapharma’s Octagam 10% now available for ordering in US

The U.S. Food and Drug Administration (FDA) has approved Octagam10% for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.

In a pivotal clinical study of adults with chronic ITP, Octagam 10% delivered rapid and sustained results without compromising tolerability. The most serious drug-related adverse event reported with Octagam 10% treatment was a headache.

"We are extremely pleased to announce U.S. product availability for Octagam 10%," said Octapharma USA President Flemming Nielsen. "The FDA approval earlier this year represented a significant expansion of Octapharma’s U.S. immune globulin therapy portfolio. We look forward to bringing more therapies to patients that demonstrate Octapharma’s commitment to the absolute highest standard of medical care."

Octapharma USA is a subsidiary of Octapharma AG, a global human protein products manufacturer, and since 2004 has been marketing Octagam 5% [Immune Globulin Intravenous (Human) 5% (50 mg/mL) Liquid Preparation] to treat Primary Humoral Immunodeficiency (PI).

FDA approval is based on the results of an Octapharma-sponsored clinical trial to evaluate the safety and efficacy of Octagam10% in 66 patients (age:17-88 years) with chronic ITP (ClinicalTrials.gov Identifier NCT00426270).

In the October 2010 issue of the journal Hematology, Robak et al published the article, "Efficacy and safety of a new intravenous immunoglobulin 10% formulation (Octagam10%) in patients with immune thrombocytopenia." The study observed that 82% of patients with chronic ITP attained the primary efficacy endpoint of clinical response (platelet count =50×109/L within seven days of dosing), which was significantly higher than the predicted responder rate of 70%.

The researchers further reported that 78% of patients with bleeding at baseline reported no bleeding on day seven and 84% of patients reported a decrease in bleeding severity by day seven. Adult patients were evaluated during a 21-day study period and at a 63-day follow-up assessment.

In this study, there were no unexpected tolerability issues even at the maximum infusion rate. Among initial study phase patients, 92% were titrated to the initial maximum infusion rate of 6 mg/kg/min (360 mg/kg/hour) and 60% of subsequent patients were titrated to the amended maximum infusion rate of 12 mg/kg/min (720 mg/kg/hour).

The most common treatment-related adverse events observed with Octagam10% treatment during the clinical trial were: headache, fever, and increased heart rate. The most serious adverse event observed with Octagam10% treatment during the clinical trial was a moderate headache.