PHARMING SUBMITS APPLICATION IN EUROPE FOR RHUCIN

Pharming Group announced that the European Medicines Agency (EMEA) has accepted its marketing authorization application for Rhucin (recombinant human C1 inhibitor) for the treatment of acute attacks of hereditary angioedema.

If approved, Rhucin will receive marketing authorization in all 25 European Union member states. Based on the standard schedule for accepted applications using the centralized procedure, Pharming anticipates that EMEA's initial response and questions concerning the application will come later this year.

The application is supported by clinical and pharmaceutical data as required by the EMEA. The data from preclinical and clinical studies reinforce the safety and effectiveness of Rhucin with rapid and sustained relief for patients with acute attacks of hereditary angioedema.

The only other approved product for the treatment of hereditary angioedema attacks is plasma-derived human C1 inhibitor, which is available in a limited number of European countries.