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news.Pharming Group's marketing authorization application for recombinant human C1 inhibitor in hereditary angioedema has been accepted for review by the European Medicines Agency, the company has revealed.
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The company also announced that it has decided to use the name Rhucin as the global trade mark for recombinant human C1 inhibitor (rhC1INH) for the treatment of acute attacks of hereditary angioedema (HAE).
The European Medicines Agency’s (EMEA) review of Pharming’s marketing authorization application (MAA) for Rhucin 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 the 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 demonstrated a rapid time to beginning of relief (typically less than two hours) and time to minimal symptoms (typically less than 12 hours).
If approved, Rhucin will represent the first new therapy for HAE patients in over 30 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.