Pharming and Santarus announce initiation of Phase IIIb clinical study with RHUCIN in Acute Hereditary Angioedema
Pharming Group NV and Santarus, Inc. announced that Pharming has begun an international, multicenter, randomized, placebo-controlled Phase IIIb clinical study evaluating the investigational drug RHUCIN® (recombinant human C1 inhibitor) for the treatment of acute attacks of angioedema in patients with hereditary angioedema (HAE). Pharming expects to enroll approximately 50 patients in the study which may provide additional data, if required by the U.S. Food and Drug Administration (FDA), in support of an approval for RHUCIN at the 50 U/kg dose. Data from the study will also be used to provide additional validation of the visual analog scale used in measuring the clinical effects of RHUCIN. The study is expected to be completed in 12 to 18 months.
The safety and efficacy of RHUCIN for the treatment of HAE attacks were previously evaluated in two randomized placebo-controlled studies and four open label treatment studies. Both placebo-controlled clinical studies showed statistically significant and clinically relevant improvement in the primary endpoint of time to beginning of relief of symptoms at RHUCIN dosage strengths of 50 U/kg and 100 U/kg compared to placebo. In October 2010, Pharming received Marketing Authorization in the European Union for RUCONEST(TM) (RHUCIN in non-European territories) for the treatment of acute angioedema attacks in patients with HAE. Pharming submitted a Biologics License Application (BLA) for RHUCIN to the FDA in late December 2010. In total, the BLA dossier included nine clinical studies covering 714 administrations in 190 subjects.
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, Pharming is responsible for conducting and paying for the current clinical study with RHUCIN in the treatment of acute attacks of angioedema in patients with HAE. 5708
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