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news.Shire has reported positive results from a Phase III trial evaluating Firazyr (icatibant) for treatment of acute attacks of hereditary angioedema (HAE).
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The study revealed that patients receiving Firazyr experienced significantly faster time to onset of symptom relief from HAE symptoms, compared to those receiving placebo.
Firazyr provided a highly statistically significant and clinically meaningful relief when compared to the placebo for the primary endpoint, which was defined as time to onset of symptom relief for the first attack after study enrollment.
The median time to onset of symptom relief for Firazyr by this measure was two hours, compared with 19.8 hours for placebo.
Firazyr also met the secondary endpoint by providing a significantly shorter time to onset of symptom relief for the patient’s primary (main) symptom.
The median time to onset of relief for Firazyr by this measure was 1.5 hours, compared with 18.5 hours for placebo.
Firazyr was generally well-tolerated during the study.
The randomised, double-blind, placebo controlled Phase III study was conducted in 67 sites in 9 countries, in which the Firazyr administered by subcutaneous injection.
The trial enrolled 88 patients who were randomised to receive either Firazyr or placebo.