FDA Approves New Drug for Hereditary Angioedema

Posted by: admin on: September 22, 2011

The US Food and Drug Administration (FDA) has approved icatibant subcutaneous injection (Firazyr) for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older.


  • Firazyr provides a new option to treat acute attacks of HAE and because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack
  • FDA approval was based on data from 3 randomized, double-blind controlled clinical trials (FAST 1, 2, and 3) of a total of 223 patients, showing that a dose of 30 mg icatibant significantly decreased the median time to symptom relief, relative to placebo.
  • These findings were corroborated by a meta-analysis of data from all 3 FAST trials, showing that patients treated with icatibant experienced a 50% reduction from baseline symptoms during a median time of 2.0 to 2.3 hours.
  • This interval did not vary with repeated treatment for the first 5 HAE events, the majority of which (93%) were resolved with a single dose.
  • Efficacy did not vary with laryngeal v/s nonlaryngeal sites of attack, nor with patient v/s clinician administration of medication.
  • Treatment-emergent adverse events most commonly included injection site reactions (97%).
  • Other adverse events that occurred more than 1% of patients were fever, transaminase increase, dizziness and rash.
  • Icatibant is already approved in 38 countries worldwide, including member states of the European Union.
  • HAE, a rare genetic disorder linked to a defect in the C1-esterase inhibitor protein, is characterized by relapsing, self-limiting episodes of edema that occur primarily in the extremities, intestinal tract, face, and larynx.
  • Abdominal symptoms include severe pain, nausea, vomiting, cramps and diarrhea; attacks that involve the face and throat can result in airway obstruction, asphyxiation, and death if left untreated.

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