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FDA approves Shire autoimmune disorder drug

Injectable Firazyr approved for condition that affects fewer than 30,000 Americans

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Shire for a rare autoimmune condition, the agency said.

The FDA announced the approval of Firazyr (icatibant) for acute attacks of hereditary angioedema in patients ages 18 years and older. HAE, which affects fewer than 30,000 people in the United States, results from improper function of C1 inhibitor, a protein that regulates how certain immune system and blood clotting pathways function.

People with the condition can develop rapid swelling of the hands, feet, limbs, face, intestinal tract and other internal organs, which can lead to disfigurement, disability and death.

"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 Office of Drug Evaluation II director Curtis Rosebraugh said.

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