EC Expands Indication for Shire’s Drug to Treat Hives

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The biotechnology company’s drug for treating hives in adults has been granted an expanded indication by the European Commission to treat children and adolescents.

On Oct. 26, 2017, Shire announced that the European Commission granted approval of Firazyr (icatibant injection) for treating hereditary angioedema (HAE) attacks, or hives, in adolescents and children aged two years and older. The drug will be available for use in pediatric patients in Europe beginning in the fourth quarter of 2017.

The anti-inflammatory drug, which was previously only approved for adults with HAE, has been approved in the European Union since 2008 for symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency. HAE is a rare genetic disease characterized by recurrent attacks of localized oedema (swelling), and can cause life-threatening attacks when upper airways are obstructed.

“Due to the unpredictable and debilitating nature of HAE attacks, children living with the condition can benefit from having a new treatment option that can provide symptomatic relief of acute HAE attacks with a subcutaneous injection,” said Henrik Balle Boysen, executive director of HAEi, the international organization for the world’s HAE patient groups, in a Shire press release. “Clinical work to bring treatment options to younger patients is vitally important and greatly appreciated by the global HAE community.”


According to Shire, an open label, non-randomized, single-arm study involving 32 pediatric HAE patients was conducted, with more than 70% of patients experienced symptom relief at 1.1 hours, and more than 90% by 2 hours after being treated with the drug.

Source: Shire, HAEi