FDA news - important for all kidney recipients

Karin

The FDA announced that it will review the iBox scoring system as a potential endpoint for transplant drugs going fwd. This is very important for all of us since this will allow for more drugs focused on long term outcomes to get approved in the future. Today, the first year survival of our grafts is excellent - over 90 percent survive - however, over time our organs do not do as well. We need better drugs to keep our gift of life alive longer!

The AST and the AST-S as well as the TTC have worked hard in this, and as Lyfebulb we have advocated at the FDA and elsewhere - we are proud of the acknowledgment and eager to see where this goes!

https://www.prnewswire.com/news-releases/transplant-therapeutics-consortium-receives-fda-acceptance-of-the-qualification-plan-for-ibox-scoring-system-302311606.html

lescp3

Great news indeed!

lescp3

Karin did you talk about this issue of endpoints in the patient summit remarks?

https://www.youtube.com/watch?v=c6wMlZ5zORY&list=PLCLzf1lGn2PbDeciSeG0WiwxGNX8lNeRv&index=1

hazzler

That is great news! Thank you for all the hard work and advocacy on our behalf. I celebrated my 35th kidneyversary this year and have asked my doctors for new medications for a long time. This is the first time I have felt any hope for the needed changes. They may not arrive in my lifetime but they are long overdue and can potentially give patients new and better options in immunosuppressant treatments.