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FDA Approves Shire's FIRAZYR® (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE)
Date:8/25/2011

nal pain.  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 2.0 hours [95% CI 1.5, 3.0] versus 19.8 hours [95% CI 6.1, 26.3], respectively (p<0.001).  The median times to almost complete symptom relief were 8.0 versus 36.0 hours for FIRAZYR and placebo, respectively.  Additional rescue medications were used by 3 patients (7%) treated with FIRAZYR and 18 patients (40%) treated with placebo.  

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 2.0 to 2.3 hours.  

In an assessment of the first 5 FIRAZYR-treated attacks (621 doses for 582 attacks), the median times to a 50% reduction from the pretreatment composite 3-itemVAS score were similar across attacks (2.0, 2.0, 2.4, 2.0, 1.5 hours).  The majority (93%) of these attacks were treated with a single dose of FIRAZYR.

Among 60 patients with laryngeal attacks who were treated with FIRAZYR, efficacy results were similar to those observed for non-laryngeal sites of attack.

Self-administration of FIRAZYR by 56 patients was assessed in an open label trial.  Patients who administered FIRAZYR during an acute attack of HAE had a median time to 50% reduction from the pretreatment composite 3-item VAS score of 2.6 hours. The safety profile in these patients was similar to that of patients whose therapy was administered by healthcare professionals.

Important Safety Information

Because laryngeal attacks may be fatal, patients with laryngeal symptoms should administer FIRAZYR and immediately seek medical attention. The most commonly reported adverse reactions were injection site reactions, which occurred in almost all patients (97%) in clinical trials. These most frequently included redness and swelling. Other common adv
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SOURCE Shire plc
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