FDA gives Dutch angioedema drug the green light
- FDA has approved Ruconest, the first recombinant C1-esterase inhibitor for treatment of hereditary angioedema (HAE).
- Ruconest was approved in Europe in 2010.
- The approval is based on a placebo-controlled trial showing rapid onset of action with respect to relief of symptoms.
HAE is a rare genetic condition that affects up to 10,000 people in the US. Symptoms include rapid swelling all over the body, including the arms, legs, hands, face, airways and intestinal tract. Without immediate treatment, HAE can be fatal.
In clinical trials, the median time for beginning of symptom relief in Ruconest-treated patients was 90 minutes, compared with 152 minutes for placebo-treated patients.
- Pharma Times FDA approves Pharming's Ruconest for HAE