-- Scott Roberts
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.
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.
The FDA has more about
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