Shire announced that Firazyr (icatibant injection), a selective bradykinin B2 receptor antagonist, has been approved for the treatment of acute attacks of hereditary angioedema (HAE) in adults ≥18 years of age. Firazyr has orphan drug designation status in the U.S. This approval was based on data from data from three double-blind, randomized, controlled clinical trials known as FAST 1, 2 and 3. FAST 3 was a placebo-controlled study of 98 adult patients. The median time to 50% reduction in symptoms for patients with cutaneous or abdominal attacks treated with Firazyr (n=43) compared to placebo (n=45) was 2 hours versus 19.8 hours (P<0.001). The median times to almost complete symptom relief were 8 hours versus 36 hours for Firazyr and placebo, respectively. FAST 1 and 2 included a total of 61 Firazyr-treated patients. Across the three controlled trials, Firazyr had a median time to 50% reduction from baseline symptoms ranging from 2 to 2.3 hours.

Firazyr will be available starting August 26, 2011 as a self-administered injection in a prefilled syringe.

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