Shire Reports FDA Approval For Label Expansion Of CINRYZE - Quick Facts

(RTTNews) - Shire plc (SHP.L, SHPG) announced the U.S. FDA has approved a label expansion for CINRYZE, making it available to help prevent angioedema attacks in children aged 6 years and older with hereditary angioedema. CINRYZE has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with hereditary angioedema.

The company said the FDA approval was based on data from a dedicated Phase 3 multicenter single-blind study that evaluated the use of CINRYZE in 12 patients living with hereditary angioedema aged 7 to 11.