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FDA allows Shire to market HAE drug

The US Food and Drug Administration (FDA) has allowed Shire to market Firazyr (icatibant injection) to treat adult patients with acute attacks of hereditary angioedema (HAE).

Earlier, Shire‘s Firazyr has been granted orphan drug status in the EU and US as a treatment for acute HAE.

Firazyr is supplied in a pre-filled syringe that can be stored at room temperature (up to 77° Fahrenheit), making it portable and accessible for immediate treatment of HAE attacks.

Shire HGT president Sylvie Gregoire said with Firazyr now approved in 38 countries, they are pleased to bring both this novel treatment and their OnePath patient service and support program to US HAE patients.