Orphan designation for Pharming's rhC1INH from FDA

Dutch biotechnology company Pharming Group NV says it has received Orphan Drug designations for recombinant human C1 inhibitor from the US Food and Drug Administration. The company has obtained this staus for rhC1INH in two separate disease indications - the prevention and/or the treatment of delayed graft function after solid organ transplantation and the treatment of capillary leakage syndrome.

Over 25,000 solid organs were transplanted in the USA in 2005, including kidney, liver, lung and heart transplants, says Pharming, noting that DGF is a common complication affecting all solid organs in the post-transplant period. DGF results in significant morbidity and mortality from early graft dysfunction and from decreased long-term graft survival.