Pharmalive -- Dr. Jason Slingsby, CEO of ProtAffin commented: “I am encouraged that the FDA has approved the Orphan Drug designation for PA401 for the prevention of delayed graft function after solid organ transplantation. This encouraging step builds on the announcement by the EMEA in July this year of granting of Orphan Medicinal Product Designation for PA401 in the EU for the same condition. There remains a real unmet medical need for an innovative anti-inflammatory product that works to prevent the delay in graft function that is so often experienced following solid organ transplants. There are no products currently authorized in the US to prevent this condition and we hope to make an important contribution to the field of clinical medicine and to improve patient outcomes in transplantation and other inflammatory diseases.”
