The Food and Drug Administration on Aug. 25 approved icatibant for the treatment of acute attacks of hereditary angioedema in adults aged 18 years and older.
Icatibant is administered subcutaneously at the onset of attack symptoms, which can include rapid swelling of different body parts – usually the face, GI tract, extremities, or genitals – with airway swelling that can increase the risk of suffocation.
"Because it can be self-administered through an injection in the abdominal area, patients can treat themselves upon recognition of an HAE attack," Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in the FDA statement announcing the approval.
Icatibant, a selective bradykinin B2 receptor antagonist, inhibits the effects of bradykinin, thought to be the cause of HAE symptoms, according to Shire Human Genetic Therapies, which will market the drug as Firazyr. One syringe costs $6,800 (average wholesale price), according to a company spokesperson. The company has a program to help eligible patients help pay for copays as well as a program to help uninsured patients or those patients whose insurance does not cover the treatment.
This is the third drug approved by the FDA to treat attacks of HAE, a rare genetic disorder that affects fewer than 30,000 people in the United States: a C1 esterase inhibitor (Berinert) was approved in October 2009, to treat facial and abdominal attacks of HAE, and ecallantide (Kalbitor) was approved in December 2009 to treat acute attacks of HAE in patients aged 16 years and older.
In three controlled studies, with open-label extension periods, 225 patients were treated with 1,076 icatibant injections. Those treated with icatibant started to experience relief of symptoms in a median of 2 hours after the injection, compared with almost 20 hours among those who received a placebo injection. The most common side effects associated with icatibant were injection site reactions, fever, elevated liver enzymes, dizziness, and rash, according to the FDA.
Icatibant, which is launching in the United States on Aug. 26, is now approved in 38 countries, including those in the European Union, according to Shire.