1. United States
2. Ill.
3. Letter

I am writing to urge your support for the next generation of immunosuppressive treatments for organ transplant recipients currently under review by the Food and Drug Administration (FDA). While lifesaving advances have been made in transplantation, progress has lagged in improving long-term post transplant outcomes. Recent discussions among transplant professionals and patient advocacy organizations have underscored the urgent need to accelerate the development and approval of new immunosuppressive therapies--particularly for kidney transplant recipients. As a transplant professional residing in your district, I respectfully ask that you sign on to the Congressional letter (https://quill.senate.gov/letters/letter/36107/opt-in/view/d25c629f-3907-47a2-94f2-b6603745524b/) requesting prompt FDA action on qualifying the Composite Biomarker Panel (iBox). The FDA is currently considering qualification of the Composite Biomarker Panel (iBox) as a reasonably likely surrogate endpoint (RLSE) for kidney transplant clinical trials under the Accelerated Approval pathway. If qualified, the Composite Biomarker Panel would be publicly available and would facilitate any drug sponsor seeking accelerated approval of novel agents, that are superior to current immunosuppressants with the potential to improve long-term survival of the transplanted kidney. This approach has the potential to meaningfully advance clinical research and hasten access to innovative treatments. I join others in urging the FDA to give serious consideration to the substantial patient need and strong clinical consensus supporting this proposal, as well as to the broader imperative to foster innovation in transplant drug development. Taking this step is essential to driving meaningful improvements in transplant patient care and ensuring continued progress in transplant medicine. We can do better for transplant recipients by modernizing immunosuppressive treatment options, which could lead to fewer post transplant complications and longer graft survival--the lifespan of the transplanted organ. Thank you for your service and for your consideration of this important issue.