HOBOKEN, NJ, USA I April 29, 2013 I The U.S. Food and Drug Administration (FDA) has accepted Octapharma USA’s Biological License Application (BLA) for octaplex®.
The FDA will evaluate the octaplex® BLA for the proposed indication of reversal of anticoagulation therapy in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures. Octaplex® is a four-factor, human prothrombin complex concentrate (PCC) consisting of factors II, VII, IX, and X in a ratio close to 1:1:1:1, as well as the thrombo-inhibitors, proteins C and S.
The American College of Chest Physicians updated their guidelines in 2012 recommending the use of 4-factor PCCs for the urgent reversal of vitamin K antagonists, such as warfarin, in cases of major bleeding.1 In 2011, the British Committee for Standards in Haemotology provided guidance recommending all hospitals that manage patients on warfarin should have available a licensed 4-factor PCC.2
Presently, 4-Factor PCC therapies are not marketed in the U.S. There are approximately 3.8 million U.S. patients on warfarin, an oral anticoagulant generally prescribed for the prevention of thrombosis and thromboembolism.3 Warfarin has a major bleed rate of 1.7% to 3.4%.4
The BLA is supported by an open label study comparing octaplex® to the current U.S. standard of care, fresh frozen plasma, in patients taking a vitamin K antagonist (e.g. warfarin) and who required urgent surgery or an immediate invasive procedure. Two primary outcome measures were studied. The first primary efficacy endpoint was the correction of international normalized ratio (INR), a measure of the blood’s tendency to clot, to
“We look forward to bringing octaplex® to the U.S. patient and medical communities,” said Octapharma USA President Flemming Nielsen. “Octaplex® is presently available in 75 countries worldwide and was first approved for use in Germany in 2003. We believe octaplex® can help fill a significant patient need.”
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for 30 years. With a broad and expanding pipeline, Octapharma’s core business is the development, production, and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immune globulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma employs more than 5,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, New Jersey. 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.octapharma.com, www.octaplasus.com, or www.wilateusa.com.
References
1 – Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH; American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S-84S
2 – Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, Kitchen S, Makris M, British Committee for Standards in H: Guidelines on oral anticoagulation with warfarin – fourth edition. British journal of haematology 2011, 154(3):311-324.
3 – AHRQ (2008); Guide to Help Patients on Coumadin®/Warfarin Therapy: http://www.ahrq.gov/legacy/news/press/pr2008/warfarinpr.htm; Accessed April 22, 2013.
4 – Schulman S, Beyth R, Kearon C, Levine M: Hemorrhagic Complications of Anticoagulant and Thrombolytic Treatment. Chest Journal 2008, 133(6):257S-298S.
SOURCE: Octapharma
Post Views: 383
HOBOKEN, NJ, USA I April 29, 2013 I The U.S. Food and Drug Administration (FDA) has accepted Octapharma USA’s Biological License Application (BLA) for octaplex®.
The FDA will evaluate the octaplex® BLA for the proposed indication of reversal of anticoagulation therapy in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures. Octaplex® is a four-factor, human prothrombin complex concentrate (PCC) consisting of factors II, VII, IX, and X in a ratio close to 1:1:1:1, as well as the thrombo-inhibitors, proteins C and S.
The American College of Chest Physicians updated their guidelines in 2012 recommending the use of 4-factor PCCs for the urgent reversal of vitamin K antagonists, such as warfarin, in cases of major bleeding.1 In 2011, the British Committee for Standards in Haemotology provided guidance recommending all hospitals that manage patients on warfarin should have available a licensed 4-factor PCC.2
Presently, 4-Factor PCC therapies are not marketed in the U.S. There are approximately 3.8 million U.S. patients on warfarin, an oral anticoagulant generally prescribed for the prevention of thrombosis and thromboembolism.3 Warfarin has a major bleed rate of 1.7% to 3.4%.4
The BLA is supported by an open label study comparing octaplex® to the current U.S. standard of care, fresh frozen plasma, in patients taking a vitamin K antagonist (e.g. warfarin) and who required urgent surgery or an immediate invasive procedure. Two primary outcome measures were studied. The first primary efficacy endpoint was the correction of international normalized ratio (INR), a measure of the blood’s tendency to clot, to
“We look forward to bringing octaplex® to the U.S. patient and medical communities,” said Octapharma USA President Flemming Nielsen. “Octaplex® is presently available in 75 countries worldwide and was first approved for use in Germany in 2003. We believe octaplex® can help fill a significant patient need.”
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma AG is one of the world’s largest human protein products manufacturers and has been committed to patient care and medical innovation for 30 years. With a broad and expanding pipeline, Octapharma’s core business is the development, production, and sale of high quality human protein therapies from both human plasma and human cell-lines, including intravenous immune globulin and von Willebrand Factor/Coagulation Factor VIII Complex. Octapharma employs more than 5,000 people and has biopharmaceutical experience in 80 countries worldwide, including the United States, where Octapharma USA is located in Hoboken, New Jersey. 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.octapharma.com, www.octaplasus.com, or www.wilateusa.com.
References
1 – Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH; American College of Chest Physicians. Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e152S-84S
2 – Keeling D, Baglin T, Tait C, Watson H, Perry D, Baglin C, Kitchen S, Makris M, British Committee for Standards in H: Guidelines on oral anticoagulation with warfarin – fourth edition. British journal of haematology 2011, 154(3):311-324.
3 – AHRQ (2008); Guide to Help Patients on Coumadin®/Warfarin Therapy: http://www.ahrq.gov/legacy/news/press/pr2008/warfarinpr.htm; Accessed April 22, 2013.
4 – Schulman S, Beyth R, Kearon C, Levine M: Hemorrhagic Complications of Anticoagulant and Thrombolytic Treatment. Chest Journal 2008, 133(6):257S-298S.
SOURCE: Octapharma
Post Views: 383
