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FDA approves Shire’s FIRAZYR

Thursday, August 25, 2011 11:33 AM

The FDA has granted marketing approval for Shire’s FIRAZYR (icatibant injection) for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

HAE is a debilitating rare genetic disease characterized by recurrent, sometimes disfiguring and often painful episodes of acute swelling which can be life-threatening in some cases. The swelling attacks can affect any part of the body but most commonly occur in the face, gastrointestinal tract, extremities or genitals. Laryngeal attacks can be fatal due to the risk of suffocation.

FIRAZYR has orphan drug designation status in the EU and US for the treatment of acute HAE. FIRAZYR is supplied in a pre-filled syringe that can be stored at room temperature making it portable and accessible for immediate treatment of HAE attacks. FIRAZYR's active substance, icatibant, is a potent and selective bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously administered approach to the treatment of HAE attacks. By inhibiting the effects of bradykinin, which is thought to be responsible for HAE symptoms of localized swelling, inflammation, and pain, FIRAZYR treats the clinical symptoms of an acute HAE attack.

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