US FDA approves CSL Behring's Berinert, the first pediatric treatment for HAE

The US Food and Drug Administration has approved the use of Berinert (esterase inhibitor [human]), CSL Behring’s 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, says the subsidiary of Australia-based CSL Limited (ASX: CSL). A child has a 50% chance of inheriting this disease if one of his or her parents has it.

“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,” he added.