New Data for HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) to be presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting
KING OF PRUSSIA, Pa., Oct. 24, 2017 /PRNewswire/ -- Global biotherapeutics leader CSL Behring announced today that new data will be presented for HAEGARDA (R) (C1 Esterase Inhibitor Subcutaneous [Human]), the company's subcutaneous preventive therapy for hereditary angioedema (HAE) attacks, at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting, Oct. 26-30, in Boston.
HAEGARDA is the first and only subcutaneous preventive therapy for HAE in the United States. Among the seven presentations are new sub-analyses from the pivotal COMPACT trial, including new pharmacoeconomic, pharmacokinetic, and pharmacodynamic analyses of HAEGARDA. Notably, a sub-analysis of the COMPACT trial on the preventive effect of HAEGARDA in patients who experience very frequent HAE attacks (i.e., more than one attack per week) will be featured as an oral presentation (Poster #OR31) on Sunday, Oct. 29 from 2:30 p.m. - 2:45 p.m.
In addition, researchers will present data on the pharmacokinetics and pharmacodynamics of subcutaneous versus intravenous C1-inhibitor for the prevention of HAE attacks. They will also present data from studies evaluating the reduction in use of rescue medications to treat breakthrough HAE attacks and potential cost offsets associated with the use of subcutaneous C1-inhibitor as long-term prophylaxis for HAE.
"We are driven by our promise to develop and deliver innovative lifesaving therapies for patients with rare diseases, including HAE. Our presence at this year's ACAAI Annual Meeting underscores our commitment to the HAE community," said Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director, CSL Limited. "We're pleased to share new clinical findings for HAEGARDA, which we hope will arm patients and physicians with more information when choosing a therapy to manage this often debilitating disease."
CSL Behring representatives will be available at booth number 2420 throughout the congress. A full list of presentations at ACAAI can be found here.
For more information about HAEGARDA, including the U.S. Prescribing Information, visit www.HAEGARDA.com.
About HAEGARDA (R) (C1 Esterase Inhibitor Subcutaneous [Human])
HAEGARDA is a self-administered, plasma-derived concentrate of C1-esterase inhibitor and the only subcutaneous therapy approved in the United States for routine prophylaxis to prevent HAE attacks in adolescent and adult patients.
HAEGARDA targets the root cause of HAE by replacing deficient or dysfunctional natural C1-INH, restoring functional C1-INH levels to above 40 percent, which is proposed to reduce the risk for HAE attacks.1 HAEGARDA is dosed based on body weight so that each patient receives an individualized amount of HAEGARDA.
About Hereditary Angioedema (HAE)
HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1-INH, a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1-INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema.2 HAE attacks can affect many parts of the body and can spread to multiple sites, including the face, abdomen, larynx, and extremities.3 Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall.4 HAE attacks that involve the face or throat can result in airway closure, asphyxiation, and, if left untreated, death.3
INDICATIONS and IMPORTANT SAFETY INFORMATION for HAEGARDA
INDICATIONS
HAEGARDA (R), C1 Esterase Inhibitor Subcutaneous (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. HAEGARDA is for subcutaneous use after reconstitution only.
IMPORTANT SAFETY INFORMATION
HAEGARDA (R), C1 Esterase Inhibitor Subcutaneous (Human), is a plasma-derived concentrate of C1 Esterase Inhibitor (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. HAEGARDA is for subcutaneous use after reconstitution only.
HAEGARDA is contraindicated in patients with a history of life-threatening hypersensitivity reactions, including anaphylaxis, to C1-INH preparations or their excipients.
Severe hypersensitivity reactions to HAEGARDA could occur. In such cases, discontinue administration and institute appropriate treatment. Epinephrine should be immediately available to treat hypersensitivity reactions.
At the recommended subcutaneous dose of HAEGARDA, no causal relationship to thromboembolic events (TEs) has been established. However, TEs have been reported with intravenous administration of C1-INH products, usually at high doses.
In clinical trials, adverse reactions observed in more than 4% of subjects treated with HAEGARDA were injection-site reactions, hypersensitivity, nasopharyngitis, and dizziness.
HAEGARDA is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent and its variant (vCJD), cannot be completely eliminated.
Full HAEGARDA Prescribing Information can be found at www.HAEGARDA.com.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs nearly 20,000 people, delivering its life-saving therapies to people in more than 60 countries. For more information visit www.cslbehring.com and follow us on www.Twitter.com/CSLBehring.
1 Longhurst H, et al. Prevention of hereditary angioedema attacks with a subcutaneous C1 inhibitor. N Eng J Med. 2017;376:1131-1140.
2 Kemp JG, et al. Variability of prodromal signs and symptoms associated with hereditary angioedema attacks: A literature review. Allergy Asthma Proc. 2009;30:492-499.
3 Agostoni A, et al. Hereditary and acquired angioedema: problems and progress: proceedings of the third C1 esterase inhibitor deficiency workshop and beyond. J Allergy Clin Immunol. 2004;114(3 Suppl):S51-131.
4 Frank MM, et al. Hereditary angioedema. J Allergy Clin Immunol. 2008;121(2):S398-S401.
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