U.S. FDA Approves CSL Behring’s Berinert® as the First and Only Pediatric Treatment for Hereditary Angioedema (HAE)
Berinert is the only C1 Esterase Inhibitor concentrate approved for on-demand treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult and pediatric patients.
KING OF PRUSSIA, Pa. — 18 July 2016
CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has approved the use of Berinert [C1 Esterase Inhibitor (Human)], its therapy for treating Hereditary Angioedema (HAE) attacks, for use in pediatric patients. This expands the use of Berinert into all age groups, making it the first and only approved HAE treatment available to patients under 12 years of age.
A child has a 50 percent chance of inheriting this disease if one of his or her parents has it. Machelle Pecoraro, HAE patient and HAE caregiver, shares “When your child has been diagnosed with HAE, you have to fight for a better life for them.”
“This is an important milestone for children living with HAE and their caregivers, to know that there is a FDA approved, safe and effective treatment option for children,” says Bob Repella, Executive Vice President, Commercial Operations, CSL Behring. “This expanded indication is an example of CSL Behring’s commitment to HAE and our continuing efforts to deliver on our promise to improve the care of patients living with serious medical conditions.”
In addition to the pediatric indication, the FDA approved an update to the Geriatric Use section of the package insert. The safety and efficacy of Berinert have been established in both children and adults, with safety profiles observed in the pediatric and geriatric populations similar to that observed in other populations. Clinical studies have shown that intervention with Berinert at the onset of an HAE attack brings significantly faster relief to a patient and reduces the severity of the attack.
Berinert is a plasma-derived C1 Esterase Inhibitor (Human) indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) attacks in adult and pediatric patients. The safety and efficacy of Berinert in preventing HAE attacks have not been established.
CSL Behring has marketed its C1 Esterase Inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is also approved and marketed in more than 20 European countries, the United States, Argentina, Australia, Canada, Israel, Japan and South Korea.
Berinert is contraindicated in individuals with a history of life-threatening systemic reactions to C1 Esterase Inhibitor preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in the placebo group. Thrombotic events have been reported in patients receiving C1 Esterase Inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.
Berinert 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 for Berinert at http://www.berinert.com/prescribing-information.aspx.
About CSL Behring
CSL Behring is a global biotherapeutics leader which is 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), headquartered in Melbourne, Australia, employs more than 16,000 people with operations in more than 30 countries. For more information visit www.CSLBehring.com and follow us on www.Twitter.com/CSLBehring.
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