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www.fdanews.com/articles/97418-pharming-reports-positive-results-in-european-placebo-controlled-trial-of-rhucin

Pharming Reports Positive Results in European Placebo-Controlled Trial of Rhucin

August 20, 2007

Dutch biotech company Pharming announced that it has completed an interim analysis of its European randomized placebo-controlled, double-blind clinical study designed to evaluate efficacy and safety of Rhucin in the treatment of acute attacks of hereditary angieoedema, a genetic disorder that causes fatal swelling of the soft tissues.

None of the patients receiving Rhucin showed a relapse of their attack, nor any treatment-related adverse events during this study, confirming the safety profile of the product as was determined in earlier studies, Pharming said.

Based on the results and after consulting with the independent data monitoring committee the company has decided to discontinue further randomized treatments within the clinical study for methodological and ethical reasons, according to the company.

Pharming added that it has included the analysis in its dossier submitted to the European Medicines Evaluation Agency to further support its request for marketing authorization in Europe.