Biotech company Pharming Group NV 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 for the treatment of acute attacks of Hereditary Angioedema (HAE) to the European Medicines Agency in September 2009. The company responded to the D120 List of Questions in March 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. In line with the regulatory timetable, the CHMP will subsequently reach its final opinion no later than Day 210.
"There are only a few minor issues left and we are confident that we will be able to provide our response quickly," said Dr Bruno Giannetti, chief operations officer of Pharming.
Rhucin (recombinant human C1 esterase inhibitor) is a human protein developed through Pharming's proprietary technology where the human protein is expressed in milk of transgenic rabbits.
Pharming Group NV is developing innovative products for the treatment of genetic disorders, ageing diseases, specialty products for surgical indications, and nutritional products.