Biotech company Pharming Group N V (Pharming) announced that its Marketing Authorization Application (MAA) for recombinant human C1 inhibitor (rhC1INH or Rhucin) for treatment of acute attacks of hereditary angioedema (HAE) has been accepted for review by the European Medicines Agency (EMEA). The company further announced that it has selected Rhucin as the global trade mark for rhC1INH for the treatment of acute HAE attacks.

The review of Pharming's MAA for Rhucin by EMEA will follow the centralized marketing authorization procedure. If approved, Rhucin will receive marketing authorization in all 25 EU 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 for Rhucin will come later this year.

The MAA is supported by clinical and pharmaceutical data on Rhucin as required by the EMEA. In clinical studies, all HAE patients treated with Rhucin demonstrate a rapid time to beginning of relief (typically less than 2 hrs) and time to minimal symptoms (typically less than 12 hrs). The data from pre-clinical and clinical studies reinforce the safety and effectiveness of Rhucin with rapid and sustained relief for patients with acute attacks of HAE.

If approved, Rhucin will represent the first new therapy for HAE patients in over thirty years. The only other approved product for the treatment of HAE attacks is plasma derived human C1 inhibitor, which is available in a limited number of European countries.

Rhucin (recombinant human C1 inhibitor) is being developed for treatment of patients with acute attacks of hereditary angioedema (HAE). HAE is a human genetic disorder caused by a shortage of C1 inhibitor activity. The disease is characterized by acute attacks of painful and in some cases fatal swelling of several soft tissues (edema), which usually last up to five days when untreated. In the Western world, approximately 1 in 30,000 individuals suffers from hereditary angioedema, having an average of seven acute attacks per year.