First Pediatric Treatment for Hereditary Angioedema Approved

The US Food and Drug Administration (FDA) has approved C1 esterase inhibitor [human] (Berinert) to treat acute abdominal, facial, or laryngeal attacks of hereditary angioedema in pediatric patients, according to an announcement made by CSL Behring.

The medication was previously approved for adult patients.

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The company noted that the safety and efficacy of the medication has been established in adults and children, adding that its safety profiles for children and geriatric patients are similar to those of other populations. Research has shown that the medication reduces the severity of attacks and brings faster relief.

An increase in the severity of pain was the most serious adverse reaction reported in patients taking the medication during clinical studies. Because it is derived from human plasma, the potential for viruses and other infectious agents is possible, the company noted.

The medication has been on the market in Germany for more than 30 years.

--Stephanie Vaccaro

Reference:

CSL Behring. US FDA approves CSL Behring's Berinert as the first and only pediatric treatment for hereditary angioedema (HAE) [press release]. www.prnewswire.com. July 18, 2016.