Label broadened to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII deficiency
KING OF PRUSSIA, PA, USA I February 28, 2013 I CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
Congenital FXIII deficiency is a rare and potentially life-threatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding. It is estimated that the condition affects one person in two million, with prevalence in the U.S. of approximately 150 people.
The expanded indication is based on use of Corifact in peri-operative situations as part of both a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study. In total, 20 patients received peri-operative management with FXIII. Neither treatment-related adverse events nor investigator-assessed serious adverse events were reported.
The post-marketing commitment trial further supports the safe and effective use of Corifact in the clinical setting and fulfills CSL Behring’s post-marketing commitment, under the FDA’s accelerated approval regulations, for Corifact.
"FDA’s decision to approve Corifact for management of peri-operative bleeding in people with congenital factor XIII deficiency is an important advance that illustrates CSL Behring’s ongoing commitment to those with rare and serious medical conditions who rely on our lifesaving therapies," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring.
About Corifact®
Corifact, an intravenous (IV) infusion given approximately every 28 days, is indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. Corifact is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. Clinical studies have shown that Corifact immediately increases FXIII levels in the blood. Corifact is dosed, depending on the patient’s weight, to maintain trough FXIII levels between 5 and 20 percent of normal.
Corifact is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life. The concentrate is stable for up to six months at room temperature (25 degrees C) and 24 months when refrigerated (2-8 degrees C). Corifact also has a low infusion volume, which could help reduce administration time.
In more than ten countries outside of the U.S., Corifact is available under the trade name Fibrogammin® P.
Corifact should not be used in individuals who experience symptoms of hypersensitivity with known anaphylactic or severe systemic reactions to human plasma-derived products. Thromboembolic complications have been reported; patients with known risk factors for thrombosis should be monitored.
In clinical studies, the most common adverse reactions reported following treatment with Corifact include joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels and increased blood lactate dehydrogenase. Physicians should monitor a patient’s trough FXIII activity level during treatment. If expected FXIII level is not attained, or breakthrough bleeding occurs, an investigation to determine the presence of FXIII inhibitor antibodies should be performed.
Corifact undergoes virus inactivation and removal for safety assurance. Corifact is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see full prescribing information at www.corifact.com.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (CSL.AX), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.
SOURCE: CSL Behring
Post Views: 194
Label broadened to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII deficiency
KING OF PRUSSIA, PA, USA I February 28, 2013 I CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
Congenital FXIII deficiency is a rare and potentially life-threatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding. It is estimated that the condition affects one person in two million, with prevalence in the U.S. of approximately 150 people.
The expanded indication is based on use of Corifact in peri-operative situations as part of both a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study. In total, 20 patients received peri-operative management with FXIII. Neither treatment-related adverse events nor investigator-assessed serious adverse events were reported.
The post-marketing commitment trial further supports the safe and effective use of Corifact in the clinical setting and fulfills CSL Behring’s post-marketing commitment, under the FDA’s accelerated approval regulations, for Corifact.
"FDA’s decision to approve Corifact for management of peri-operative bleeding in people with congenital factor XIII deficiency is an important advance that illustrates CSL Behring’s ongoing commitment to those with rare and serious medical conditions who rely on our lifesaving therapies," said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring.
About Corifact®
Corifact, an intravenous (IV) infusion given approximately every 28 days, is indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. Corifact is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. Clinical studies have shown that Corifact immediately increases FXIII levels in the blood. Corifact is dosed, depending on the patient’s weight, to maintain trough FXIII levels between 5 and 20 percent of normal.
Corifact is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life. The concentrate is stable for up to six months at room temperature (25 degrees C) and 24 months when refrigerated (2-8 degrees C). Corifact also has a low infusion volume, which could help reduce administration time.
In more than ten countries outside of the U.S., Corifact is available under the trade name Fibrogammin® P.
Corifact should not be used in individuals who experience symptoms of hypersensitivity with known anaphylactic or severe systemic reactions to human plasma-derived products. Thromboembolic complications have been reported; patients with known risk factors for thrombosis should be monitored.
In clinical studies, the most common adverse reactions reported following treatment with Corifact include joint inflammation, hypersensitivity, rash, pruritus, erythema, hematoma, arthralgia, headache, elevated thrombin-antithrombin levels and increased blood lactate dehydrogenase. Physicians should monitor a patient’s trough FXIII activity level during treatment. If expected FXIII level is not attained, or breakthrough bleeding occurs, an investigation to determine the presence of FXIII inhibitor antibodies should be performed.
Corifact undergoes virus inactivation and removal for safety assurance. Corifact is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.
Please see full prescribing information at www.corifact.com.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited (CSL.AX), a biopharmaceutical company headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.
SOURCE: CSL Behring
Post Views: 194
