Pharming seeks EMEA nod for Rhucin to treat hereditary angioedema

Biotechnology company Pharming Group NV announced that it has submitted the Marketing Authorization Application (MAA) for Rhucin for the treatment of acute attacks of hereditary angioedema (HAE) to the European Medicines Agency (EMEA).

In this new MAA, Pharming has followed up on and addressed concerns raised by the CHMP during the former evaluation procedure in 2007. In particular, the size of the clinical database has been significantly expanded, additional clinical efficacy and safety data have been collected and analyzed, and an analysis of immunogenicity data after (repeat) treatment with Rhucin has been completed.

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