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Pharming, Santarus File BLA

Rhucin application at FDA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pharming Group NV and Santarus, Inc. have submitted a BLA to the FDA to obtain marketing approval for Rhucin (recombinant human C1 inhibitor) for the treatment of acute angioedema attacks in patients with Hereditary Angioedema (HAE). 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 showed statistically significant and cl...

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