From cslbehring.com July 18, 2016 News, Press Release

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) attacks 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.

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