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The submission includes data from two completed trials of RUCONEST® for the prophylaxis of HAE attacks:  a randomized, double-blind, placebo-controlled trial and an open-label study. The two studies enrolled a total of 56 patients and showed consistent efficacy and safety results.
 

“HAE patients in the US are currently facing a shortage of plasma-derived C1 inhibitor used to prevent attacks."

- Dr. Bruno Giannetti, Pharming's COO
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