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Home Industry News Shire receives EU approval for paediatric use of Firazyr

Shire receives EU approval for paediatric use of Firazyr

30th October 2017

Shire has announced that its hereditary angioedema (HAE) therapy Firazyr has been approved for use in paediatric indications in Europe.

The European Commission has approved a label extension granting a new indication for Firazyr, allowing it to be used in adolescents and children aged two years and older with HAE caused by C1-esterase-inhibitor C1-INH deficiency.

This approval was based on clinical study data showing that Firazyr is well-tolerated and associated with a rapid resolution of symptoms during HAE attacks through a single injection.

The study was notable for being the first and only trial investigating a subcutaneous therapy in the HAE paediatric population.

Jennifer Schranz, global development lead for hereditary angioedema at Shire, said: "This approval in Europe demonstrates our unwavering commitment to helping patients and represents a significant advance for paediatric patients, who now have a subcutaneous treatment option for acute HAE attacks."

Firazyr has been approved in the EU since 2008 for the symptomatic treatment of acute attacks of HAE in adults with C1-INH deficiency.

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