Firazyr Approved for Acute Hereditary Angioedema

Most common side effects: injection site reactions, fever, increase in liver enzymes, dizziness, rash

THURSDAY, Aug. 25 (HealthDay News) -- Firazyr (icatibant) has been approved by the U.S. Food and Drug Administration to treat acute attacks of hereditary angioedema (HAE) in adults.

The rare genetic condition is caused by low amounts of the protein, C1 inhibitor. Fewer than 30,000 people in the United States have the condition, the agency said in a news release. It causes potential symptoms including rapid swelling of the hands, feet, limbs, face, intestines and voice pipe.

The drug's safety and effectiveness were evaluated in clinical testing involving 225 patients. Symptom relief took an average of two hours among people who took the drug, versus almost 20 hours among those who took a placebo, the agency said.

The most common side effects included injection site reactions, fever, an increase in liver enzymes, dizziness and rash. Two other drugs, Berinert and Kalbitor, were approved previously to treat symptoms of HAE, the FDA said.

Firazyr is marketed by Shire Human Genetic Therapies, based in Cambridge, Mass.

More information

The U.S. Hereditary Angioedema Association has more about this condition.

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