Investigational drug Ruconest 50 U/kg is being developed for the treatment of acute angioedema attacks in patients with hereditary angioedema (HAE).
A Phase III randomized placebo-controlled study conducted under a special protocol assessment agreement with the FDA, evaluated the safety and efficacy of Ruconest in treating HAE attacks.
Ruconest demonstrated a statistically significant and clinically relevant improvement in primary endpoint of time to beginning of relief of symptoms compared with placebo.
Under an agreement signed between the two companies, Santarus licensed certain exclusive rights to commercialize Ruconest in North America for acute attacks of HAE in addition to other potential future indications from Pharming.