CSL Behring Receives FDA Approval to Expand the Indication for Corifact®
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., Feb. 28, 2013
KING OF PRUSSIA, Pa., Feb. 28, 2013 /PRNewswire/ --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,
"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.
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
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 (ASX:CSL), a biopharmaceutical company headquartered in Melbourne,
Australia. For more information, visit http://www.cslbehring.com/.
Senior Manager, Public Relations & Communications
SOURCE CSL Behring
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