Santarus, Inc. (SNTS) and Pharming Group NV (PHGUF.OB) Wednesday announced the submission of a Biologics License Application or BLA to the U.S. Food and Drug Administration to obtain marketing approval for Ruconest (recombinant human C1 esterase inhibitor) 50 U/kg, an investigational drug for the treatment of acute angioedema attacks in patients with hereditary angioedema or HAE.
The safety and efficacy of Ruconest for the treatment of HAE attacks were evaluated in a clinical program that included a Phase III randomized placebo-controlled study conducted under a Special Protocol Assessment agreement with the FDA.
The pivotal Phase III clinical study showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms for Ruconest compared to placebo.
The Ruconest clinical program also included two additional randomized placebo-controlled studies and four open label treatment studies. Totally, the BLA dossier includes ten clinical studies covering 940 administrations in 236 subjects.
Santarus licensed some exclusive rights from Pharming to commercialize Ruconest in North America for the treatment of acute attacks of HAE as well as other potential future indications.
Under the terms of the license agreement, a $5 million milestone is payable to Pharming upon FDA acceptance for review of the BLA for Ruconest.
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