FDA Approves Ruconest for Hereditary Angioedema
Human recombinant C1-esterase inhibitor approved to treat hereditary angioedema
THURSDAY, July 17, 2014 (HealthDay News) -- Ruconest, a human recombinant C1-esterase inhibitor, has been approved by the U.S. Food and Drug Administration to treat hereditary angioedema.
Hereditary angioedema affects as many as 10,000 people in the United States. Ruconest, produced from the milk of genetically-modified rabbits, is intended to restore the level of functional C1-esterase inhibitor in a patient's plasma, thus reducing swelling, 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, N.C.