Shire Reports Positive Efficacy And Safety Results From FAST-3 Study Of Firazyr® (icatibant) For Acute Attacks Of Hereditary Angioedema

Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced topline results from FAST-3 (For Angioedema Subcutaneous Treatment), the largest of the Phase III trials studying the use of Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).


The study showed that patients receiving treatment with Firazyr experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to those receiving placebo.


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