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news.Santarus and Pharming Group have submitted biologics license application (BLA) with the US Food and Drug Administration (FDA) to get the marketing approval for Rhucin (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE).
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The safety and efficacy of Rhucin for the treatment of HAE attacks were evaluated in two randomized placebo-controlled studies and are supported by four open label treatment studies.
Both placebo-controlled clinical studies clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms at Rhucin dosage strengths of 50U/kg and 100U/kg compared to placebo.
Santarus has licensed certain exclusive rights from Pharming to commercialize Rhucin in North America for the treatment of acute attacks of HAE and other future indications.
Under the terms of the license agreement, a $5m milestone is payable to Pharming upon FDA acceptance for review of the BLA for Rhucin.