Pharming Group N.V.
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Publicatie datum
17 aug 2006 - 17:59
Statutaire naam
Pharming Group N.V.
Titel
PHARMING’S MARKETING AUTHORIZATION APPLICATION FOR RHUCIN® (RHC1INH) ACCEPTED FOR REVIEW BY EMEA
Bericht
Leiden, The Netherlands, August 17, 2006. Biotech company Pharming Group N.V. (“Pharming”) (Euronext: PHARM) (PHARM.AS) announced today 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. Further information on EMEA procedures can be found at www.emea.eu.int.
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 preclinical 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.
Datum laatste update: 17 januari 2025