Health
Transplant Therapeutics Consortium Receives FDA Notice of Reviewability for the iBox Scoring System Full Qualification Package
The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics Consortium (TTC) received notification from FDA of the Reviewability of the Full Qualification Package (FQP) for the iBox Scoring System, a novel reasonably likely surrogate efficacy endpoint for kidney transplant clinical trials. The FDA Drug Development Tool qualification program aims to communicate the final decision within 10 months targeting April
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[{"type":"text","content":"The iBox Scoring System is a novel composite biomarker endpoint predictive of long-term graft survival after kidney transplantation","length":131,"tagName":"p","attribs":{}},{"type":"text","content":"On track to be the first qualified reasonably likely surrogate endpoint in transplant for use in the FDA accelerated approval pathway","length":133,"tagName":"p","attribs":{}},{"type":"text","content":"FDA aims for a 10 month review of the Full Qualification Package","length":64,"tagName":"p","attribs":{}},{"type":"text","content":"MOUNT LAUREL, N.J., July 30, 2025 /PRNewswire/ -- The American Society of Transplant Surgeons (ASTS) and American Society of Transplantation (AST) announced today that the Transplant Therapeutics Consortium (TTC) received notification from FDA of the Reviewability of the Full Qualification Package (FQP) for the iBox Scoring System, a novel reasonably likely surrogate efficacy endpoint for kidney transplant clinical trials. The FDA Drug Development Tool qualification program aims to communicate the final decision within 10 months targeting April 2026. The Full Qualification Package is the final step in the FDA qualification process and iBox scoring system is the first transplant endpoint to reach this stage of qualification.","length":738,"tagName":"p"},{"type":"image","alt":"Transplant Therapeutics Consortium (PRNewsfoto/American Society of Transplantation)","displaySize":"","headline":null,"caption":"Transplant Therapeutics Consortium (PRNewsfoto/American Society of Transplantation)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":253,"url":"https://media.zenfs.com/en/prnewswire.com/3047e6cefe54573097176c2650fdcfe3"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/he8UMvurslzJe4yWLZ1HDw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTQ0NjtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/3047e6cefe54573097176c2650fdcfe3","width":400,"height":253}},"href":"https://mma.prnewswire.com/media/2561059/American_Society_of_Transplantation_consortium_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Improving the long-term survival of transplanted kidneys is an important area of unmet need for transplantation recipients. The current efficacy failure endpoint has typically shown non-inferiority of immunosuppressive regimens but the iBox Scoring System is ...