Shire announced that the European Commission (EC) has approved a label extension for drug Cinryze for use in pediatrics.

Consequently, Cinryze is now approved for routine prevention of angioedema attacks in children (aged 6 years and above) with severe and recurrent attacks of hereditary angioedema (HAE) who are intolerant to or insufficiently protected by oral preventions treatments, or patients who are inadequately managed with repeated acute treatments.

The drug is now approved for the treatment and pre-procedure prevention of angioedema attacks in children (aged 2 years and above) with HAE.   

The drug was approved for these indications in adults and adolescents aged 12-17 years with HA since 2011.

Cinryze recorded sales of $680.2 million in 2016, up 10% driven by an increase in the number of patients on therapy which was partially offset by reduced utilization as a result of a supply constraint in the U.S. during the second half of the year.

A label expansion of the drug is likely to boost sales further. Shire acquired ViroPharma in 2014 and added Cinryze to its portfolio. Cinryze complements Shire's Firazyr, which is indicated for the on-demand treatment of acute HAE attacks. The acquisition of Dyax added Kalbitor to Shire’s HAE portfolio.