Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks from childhood into adulthood.
Shire announced today that the U.S. FDA accepted the Cinryze (C1 esterase inhibitor [human]) supplemental biologics license application to expand the currently approved indication to include children aged 6 years and older with hereditary angioedema. The filing has received priority review designation from the FDA, which means Cinryze has an accelerated review target of eight months, instead of the standard of 12 months. The FDA is expected to provide a decision on the expanded indication of Cinryze by 20 June 2018, based on the Prescription Drug User Fee Act V action date.
