Cutaneous & Abdominal Attacks

FIRAZYR was shown to be effective in reducing symptoms of an HAE attack

FIRAZYR can be used to treat all types of acute hereditary angioedema (HAE) attacks: cutaneous, abdominal, and laryngeal.1

  • In the pivotal trial (Trial 1):
    • The median time to 50% reduction in symptoms was 2.0 hours for those treated with FIRAZYR vs 19.8 hours for those given placebo (P<0.001)1
    • The median time to almost complete symptom relief was 8.0 hours vs 36.0 hours for FIRAZYR and placebo, respectively1
  • In a second placebo-controlled trial and an active-controlled trial, a total of 26 and 35 patients, respectively, received FIRAZYR for the treatment of an acute HAE attack1
  • Across the 3 controlled trials, median time to 50% reduction from baseline symptoms ranged from 2.0 to 2.3 hours in patients treated with FIRAZYR (N=223)1
  • 9 of 10 attacks were treated with a single dose of FIRAZYR1
Graph displaying how patients experienced faster relief with FIRAZYR® (icatibant injection) vs placebo as demonstrated in Fast-3 (Trial 1)

Trial 1 study design1

Trial 1 was a randomized, placebo-controlled, double-blind, parallel-group study of 98 adult patients with a median age of 36 years. Patients who had developed moderate to severe cutaneous or abdominal or mild to moderate laryngeal attacks of HAE were randomized to receive either FIRAZYR 30 mg or placebo by subcutaneous injection. Patients with severe laryngeal attacks of HAE received open-label FIRAZYR 30 mg. The primary endpoint was assessed using a 100 mm 3-item composite visual analog score (VAS), comprising averaged assessments of skin swelling, skin pain, and abdominal pain. Response was defined as at least a 50% reduction from the pretreatment composite 3-item VAS score.