Ruconest approved by FDA for treatment of Hereditary Angioedema - Salix Pharma
Salix Pharmaceuticals, Ltd. and Pharming Group NV announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with Hereditary Angioedema (HAE).
Because of the limited number of patients with laryngeal attacks, effectiveness was not established in HAE patients with laryngeal attacks. Hereditary angioedema, which is caused by having insufficient amounts of a plasma protein called C1-esterase inhibitor, affects approximately 6,000 to 10,000 people in the United States. The safety and efficacy of Ruconest was evaluated in a multicenter controlled clinical trial. Forty-four adult and adolescent patients with acute attacks were treated with Ruconest. The most common adverse reactions reported in patients treated with Ruconest were headache, nausea and diarrhea.
Rhucin (the European name of the drug) was approved in the EU in October 2010 and is marketed there by Swedish Orphan Biovitrium.
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