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.

-Team@CMHF

• 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.

For further reading log on to

http://www.medscape.com/viewarticle/748570?src=mpnews&spon=34