Cinryze Approved for Preventing Pediatric Angioedema Attacks

The U.S. Food and Drug Administration (FDA) has approved Shire’s Cinryze (C1 esterase inhibitor [human]) to prevent angioedema attacks in children 6 years and older with hereditary angioedema (HAE). First approved in 2008 for routine preventive treatment against attacks in adults and teens with HAE, this label extension makes Cinryze the first approved treatment in the U.S. to help prevent angioedema attacks in children as young as 6 years old.

Approval was based on data from a pediatric Phase III study that included 12 patients ages six years through 11 years who had at least one angioedema attack per month. The children received Cinryze either in a 500-unit or 1,000-unit dose every three to four days for 12 weeks. Results showed patients had fewer and less severe attacks when taking Cinryze compared to a placebo. Five hundred units of Cinryze reduced the number of angioedema attacks per month by 71.1 percent, and 1,000 units reduced attacks by 84.5 percent. Patients also reduced the use of acute treatment after taking Cinryze. The most common adverse reactions were headache, nausea, fever and redness of the skin at the infusion site.