EU extends label of Cinryze (C1 inhibitor [human]) for children with hereditary angiodema (HAE).-Shire plc

Shire plc announced that the European Commission (EC) has approved a label extension granting three new indications for Cinryze (C1 inhibitor [human]), broadening its use to children with Hereditary angiodema (HAE), a rare, genetic disorder that results in recurring attacks of edema (swelling). The body sites most commonly affected are mainly the extremities and abdomen.

Cinryze is now indicated for routine prevention of angioedema attacks in children (ages 6 years and above) with severe and recurrent attacks of HAE who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatment. It is the first and only HAE treatment with this indication in paediatric patients.

Cinryze is also now approved for the treatment and pre-procedure prevention of angioedema attacks in children (ages 2 years and above) with HAE. Symptoms of HAE often present in childhood, and while attacks can occur at any age, early onset may predict a more severe disease course. Attacks often occur in children without a clear trigger, and may affect a child�s participation in school, activities, and sports, which can leave them feeling socially isolated. Less frequently, HAE can cause life-threatening attacks due to obstruction in the upper airways.