HOBOKEN, N.J.--(BUSINESS WIRE)--Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation] for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding.
The FDA approval marks a significant expansion of Octapharma’s U.S. immune globulin therapy portfolio. 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).
“The FDA approval of Octagam 10% represents a significant Octapharma milestone, but, more importantly, opens up new treatment options for patients,” said Octapharma USA President Flemming Nielsen. “Octagam 10% has demonstrated safety and efficacy in a pivotal clinical trial. Octapharma looks forward to providing the product in the U.S., further advancing our vision of providing patients with therapies to treat life-threatening conditions.”
Octagam 10% is expected to be available in the U.S. in September 2014. Further details will be announced shortly.
The approval of Octagam 10% is based on the results of an Octapharma-sponsored clinical trial to evaluate the safety and efficacy of Octagam 10% 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 (Octagam 10%) 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 7 days of dosing), which was significantly higher than the predicted responder rate of 70%. In this study, there were no unexpected tolerability issues even at the maximum infusion rate of 0.12 mL/kg/minute (720 mg/kg/hour). The researchers further reported that 78% of patients with chronic ITP, who had bleeding at baseline, reported no bleeding 7 days after treatment.1, 2, 3
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 Octagam 10% treatment during the clinical trial was a moderate headache. 2
About Octagam 10% liquid
Octagam 10% [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. Octagam 10% is a solvent/detergent (S/D) treated, sterile preparation of highly purified immunoglobulin G (IgG) derived from large pools of human plasma. Octagam 10% is a solution for infusion to be administered intravenously.
WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE
Please see full prescribing information for complete boxed warning.
- Thrombosis may occur with immune globulin intravenous (IGIV) products, including Octagam® 5% and Octagam 10% liquid. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors.
- Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Octagam® 5% and Octagam 10% liquid does not contain sucrose.
- For patients at risk of thrombosis, renal dysfunction or renal failure, administer Octagam® 5% and Octagam 10% liquid at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.
CONTRAINDICATIONS
Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
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.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.
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