Pharming announces completion of randomized treatments in North American clinical trial with Rhucin

31-Oct-2007

Pharming Group N.V. announced that it has completed randomized treatments in its North American clinical trial assessing the safety and efficacy of Rhucin® (recombinant human C1 inhibitor) to treat acute attacks of hereditary angioedema (HAE). The Company plans to continue an open label study with Rhucin® for hereditary angioedema patients at sites across the United States and Canada.

In the study, 39 patients with acute attacks of HAE were treated with either Rhucin® (100U/kg or 50U/kg) or placebo. In the follow-up, patients with acute attacks of HAE were eligible to receive open label treatments with the product. The site of attacks treated in HAE patients included laryngeal, facial, abdominal, urogenital and peripheral. In total, 55 acute attacks of HAE were treated.

While the results of the placebo-controlled trial will be analyzed and announced after the completion of the follow up of the last patient later this quarter, the results of the open-label treatments were positive and in line with earlier published data. All patients responded favourably to the treatment and no relapses or treatment-related adverse events were recorded.

Recently, Pharming announced positive safety and efficacy results of Rhucin® from a randomized clinical trial conducted in Europe. The primary and secondary endpoints of the study demonstrated statistical and clinical significance. None of the patients receiving Rhucin® showed a relapse of the HAE attack or any treatment related adverse events, confirming the safety and efficacy profile of the product.

Pharming has filed a Marketing Authorization Application for Rhucin® with the European Medicines Agency (EMEA). Based on EMEA timelines, Pharming expects an opinion of the scientific committee of the EMEA later this year. The EMEA has already confirmed that all facilities and processes involved in the manufacturing of Rhucin® operate in accordance with Good Manufacturing Practice (GMP) standards.

https://www.bionity.com/en/news/72629/pharming-announces-completion-of-randomized-treatments-in-north-american-clinical-trial-with-rhucin.html