In Europe, Shire broadens Firazyr label to include children

Rare disease specialist Shire has been granted a label extension in Europe for its hereditary angioedema (HAE) therapy Firazyr (icatibant).

The therapy may now be marketed for adolescent and child patients aged at least two. The drug has been approved for adults since 2008.

HAE is a rare genetic disease characterized by recurrent attacks of localized oedema (swelling). HAE can cause life-threatening attacks due to obstruction in the upper airways.

The approval was based on a study in which the therapy: “Demonstrated rapid resolution of symptoms during an HAE attack through a single injection.”