Posted by Michael Wonder on 21 Jun 2018
Shire announces FDA approval for label expansion of Cinryze (C1 esterase inhibitor [human]) for prevention of attacks in paediatric hereditary angioedema patients
21 June 2018 - Shire is the only drug developer to complete a paediatric study for the prophylactic treatment of hereditary angiodema.
Shire today announced that the U.S. FDA has approved a label expansion for Cinryze (C1 esterase inhibitor [human]), making it available to help prevent angioedema attacks in children aged 6 years and older with hereditary angioedema (HAE). Cinryze has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE.
The approval was based on data from a dedicated Phase 3 multi-center single-blind study (0624-301) that evaluated the use of Cinryze in 12 patients living with HAE aged 7 to 11.
