Ruconest – the first recombinant C1 inhibitor for the treatment of HAE attacks

The European Commisioin has granted Pharming Marketing Authorization for its lead product Ruconest for the treatment of acute attacks of Hereditary Angioedema. Ruconest is now approved for use in the 27 EU countries including Romania, plus Norway, Iceland and Liechtenstein. Patients suffering from HAE experience unpredictable, painful and debilitating attacks, due to reduced levels of C1 inhibitor, resulting in intense swelling of parts of the body (for example, face, throat, abdomen) which can last up to five days if left untreated. Ruconest is a recombinant version of the human C1 inhibitor protein, produced by Pharming's proprietary transgenic technology. As published in last October's issue of the Journal of Allergy and Clinical Immunology, Ruconest has been shown to have excellent efficacy and safety. Pharming has withdrawn the orphan status application in order to avoid delays in commercializing the product. (Source: Pharming Group N.V. via Thomson Reuters ONE şi Agenţia Europeană a Medicamentului)