Immune Therapy Delivers Rapid and Sustained Results without Compromising Tolerability for Treatment of Chronic ITP Adult Patients
HOBOKEN, N.J. (October 27, 2014) - Octapharma USA today announced that Octagam10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation]is available for ordering within the U.S.
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.1,2
"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).1, 2
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.2
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).1, 2
The most common treatment-related adverse events observed with Octagam 10% 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. 2
About Octagam10% liquid
Octagam10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation] is indicated for chronic ITP in adults to rapidly raise platelet counts to control or prevent bleeding. Octagam10% is a solvent/detergent (S/D) treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam10% is a solution for infusion to be administered intravenously.
WARNINGS AND PRECAUTIONS
IgA-deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions to Octagam 10%. Epinephrine should be available immediately to treat any severe acute hypersensitivity reactions. Monitor renal function, including blood urea nitrogen and serum creatinine, and urine output in patients at risk of developing acute renal failure. Falsely elevated blood glucose readings may occur during and after the infusion of Octagam 10% with testing by some glucometers and test strip systems. Hyperproteinemia, increased serum osmolarity and hyponatremia may occur in patients receiving Octagam 10%. Thrombotic events may occur. Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for those at risk of hyperviscosity. Aseptic Meningitis Syndrome may occur in patients receiving Octagam 10%, especially with high doses or rapid infusion. Hemolytic anemia can develop subsequent to IGIV treatment. Monitor patients for hemolysis and hemolytic anemia. Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury (TRALI)). Octagam 10% is made from human plasma and may contain infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease agent.
For full prescribing information, please visit www.octagamus.net.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG, a global company dedicated to the research and manufacture of human proteins, has been committed to patient care and medical innovation for more than 30 years. Its core business is the development, production and sale of human proteins from human plasma and human cell-lines. Patients in over 100 countries are treated with Octapharma products in the therapeutic areas of hematology, immunotherapy, and critical care. The company's American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates two state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com, www.octagamus.net, www.octaplasus.com or www.wilateusa.com.
REFERENCES
1. Octagam 10% [Immune Globulin Intravenous (Human)] Liquid Preparation. Complete Prescribing Information. Octapharma. Hoboken, New Jersey, USA.
2. Robak, T, Mainau, C, Pyringer, B et al. Efficacy and safety of a new intravenous immunoglobulin 10% formulation (Octagam 10%) in patients with immune thrombocytopenia, Hematology, 2010 Oct;15(5):351-359.
3. Octapharma, Data on File. 2014
Forward-looking Statements
This news release contains forward-looking statements, which include known and unknown risks, uncertainties, and other factors not under the company's control. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. These factors include results of current or pending research and development activities and action by the FDA or other regulatory authorities.