The US Food and Drug Administration today approved Firazyr (icatibant) Injection for the treatment of acute attacks of hereditary angioedema (HAE) in people ages 18 years and older.
In March this year, the European Commission approved the self-administration label for the drug, which is the first and only treatment for acute Type I and Type II HAE.
The label change is valid in all of the 27 EU Member States, as well as Iceland, Liechtenstein and Norway.
“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,” said Curtis Rosebraugh, Director of the Office of Drug Evaluation II in the FDA’s Centre for Drug Evaluation and Research.
The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.
The FDA approved Firazyr with patient counseling information that includes injection instructions. The most common side effects reported by those using Firazyr were injection site reactions, fever, increased liver enzymes, dizziness, and rash.