Pharming's C1 inhibitor granted IND for kidney transplants
This article was originally published in Scrip
Executive Summary
Pharming's recombinant human C1 inhibitor product has been granted an investigational new drug (IND) application by the US FDA for preventing antibody-mediated rejection in kidney transplantation. The Netherlands-based biotech is to conduct clinical trials examining the product's impact on inflammatory damage and kidney graft loss, compared with current treatment. Pharming has also developed its recombinant human C1 inhibitor as Rhucin for hereditary angioedema. Rhucin has been received a negative opinion from the EU's CHMP, but the product is being developed with a view to US filing.