Firazyr Available Soon for Acute Attacks of Hereditary Angioedema

Firazyr Available Soon for Acute Attacks of Hereditary Angioedema
Firazyr Available Soon for Acute Attacks of Hereditary Angioedema
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.

For more information call (800) 536-7878 or visit www.firazyr.com.