Ruconest BLA Under Review for Acute Hereditary Angioedema

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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