Santarus and Pharming Group NV announced that the FDA has accepted for filing the Biologics License Application (BLA) for the investigational drug Ruconest (INN conestat alfa) 50 IU/kg for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE). Ruconest is a recombinant human C1 esterase inhibitor produced with Pharming’s proprietary transgenic technology.

The safety and efficacy of Ruconest for the treatment of HAE attacks was evaluated in a clinical program that included a Phase 3 randomized placebo-controlled study. The Ruconest clinical program also included two additional randomized placebo-controlled studies and several open label treatment studies.

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