Pharming appeals CHMP Rhucin rejection

Leiden, the Netherlands-based biotechnology firm Pharming NV has given written notice to the European Medicines Agency (EMEA) for re-examination of a negaitve opinion issued by the Committee for Medicinal Products for Human Use (CHMP) on its recombinant human C1 inhibitor, Rhucin.

The Dutch firm says its believes that the findings of clinical studies have demonstrated clear evidence of Rhucin's efficacy and safety in the treatment of acute hereditary angioedema attacks. In a randomized placebo-controlled study, Rhucin showed statistically-significant superiority over placebo in time to first relief of the attack and in time to minimal symptoms. These results have been accepted by the CHMP. No patient experienced a relapse of the HAE-attack or any treatment-related adverse event. Pharming is, therefore, convinced that the available data submitted to the CHMP demonstrate that Rhucin is safe and efficacious in the treatment of acute HAE attacks and provide a sound basis for granting a marketing authorization in the European Union.