Pharming Group receives D180 List of Outstanding Issues on Rhucin MAA.

Pharming Group NV has reported that it has received the Day 180 List of Outstanding Issues (LoOI) from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). Pharming submitted the Marketing Authorization Application (MAA) for Rhucin (recombinant human C1 esterase inhibitor) for the treatment of acute attacks of hereditary angioedema (HAE) to the European Medicines Agency in Sep 2009. The company responded to the D120 List of Questions in Mar 2010. After review of the response, the CHMP has now summarized its outstanding questions in the Day 180 LoOI. Pharming plans to submit its response to these questions within the regular one month clock stop period. …