Label extension for Cinryze in Europe

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 drug’s maker, Ireland-headquartered Shire (LSE: SHP), says that Cinryze is now indicated for routine prevention of angioedema attacks in children (ages six 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 pediatric patients. Cinryze is also now approved for the treatment and pre-procedure prevention of angioedema attacks in children (ages two years and above) with HAE. Shire gained rights to the drug along with its $4.2 billion acquisition of ViroPharma in 2013. Cinryze generated sales of $680 million for the company in 2016.