Phase 3 study of Firazyr for the treatment of hereditary angioedema (HAE)

Shire announced topline results from FAST-3, the largest of its Phase 3 trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE). The FAST-3 (For Angioedema Subcutaneous Treatment) study, conducted in 67 sites in 9 countries, was a randomized, double-blind, placebo controlled multicenter trial of Firazyr administered by subcutaneous injection for the treatment of patients with acute attacks of HAE. Firazyr provided a highly statistically significant and clinically meaningful benefit relative to placebo for the primary endpoint of time to onset of symptom relief for the first attack after study enrollment. This was measured by a 50% reduction in a composite symptom score assessed by the patient. The median time to onset of symptom relief for Firazyr by this measure was 2.0 hours, compared with 19.8 hours for placebo. Firazyr also provided a significantly shorter time to onset of symptom relief of the patient's primary (main) symptom. This secondary efficacy endpoint was measured by a 30% reduction in symptom score. The median time to onset of relief for Firazyr by this measure was 1.5 hours, compared with 18.5 hours for placebo. The results for both of these endpoints were highly statistically significant (p<0.001).

Firazyr is a specific bradykinin B2 receptor antagonist. It represents a novel, targeted, subcutaneously-administered approach to the treatment of HAE attacks by blocking effects of bradykinin, the key mediator of edema formation.

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