July 19, 2014
THURSDAY, July 17, 2014 (HealthDay News) — Ruconest has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema, a genetic disease that leads to sudden and potentially fatal swelling of the hands, feet, limbs, face, intestinal tract or airways.
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The disease, affecting as many as 10,000 people in the United States, is caused by the body’s inability to produce enough of a plasma protein called C1-esterase inhibitor. The remedy is produced from the milk of genetically-modified rabbits, the FDA said Thursday in a news release.
Ruconest was evaluated in a clinical study of 44 adults and adolescents with hereditary angioedema. The most common side effects recorded were headache, nausea and diarrhea.
Ruconest is manufactured by the Netherlands-based Pharming Group NV, and will be distributed by a subsidiary of Salix Pharmaceuticals, based in Raleigh, NC.
— Scott Roberts
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