Shire’s icatibant set to met endpoint in hereditary angioedema
Dublin – Shire plc is set to reach the primary endpoint in its largest and pivotal Phase III trial for FDA approval with its bradykinin B2 receptor antagonist bradykinin FIRAZYR® (icatibant) for treatment of acute attacks of hereditary angioedema (HAE). According to the company, patients under icatibant treatment experienced a significantly faster time to onset of symptom relief from individual and combined cutaneous and abdominal HAE symptoms, compared to those receiving placebo. The median time to onset of symptom relief for icatibant by this measure was 2.0 hours, compared with 19.8 hours for placebo. Additionally the drug, originally developed by German Jerini AG, 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). Consistent with previous studies, FIRAZYR was generally well tolerated.