The US Food and Drug Administration (FDA) on Friday finalized guidance to help sponsors develop drugs to prevent delayed graft function (DGF) in kidney transplant patients.
The 11-page guidance outlines the clinical and safety considerations, noting expectations for two adequate, well-controlled superiority trials where a treatment to reduce the risk of DGF is compared to placebo. A single adequate and well-controlled trial may also be allowed in certain circumstances.
As far as changes between the draft and final guidance, FDA said in the Federal Register that it “considered the few public comments received on the draft guidance and appropriate changes were made, including a rationale for the recommended number of patients for a preapproval safety database. Other edits were made to the
efficacy endpoints and accelerated approval sections for improved clarity on those topics.”
The guidance recommends a preapproval safety database of 300 patients or more on the investigational drug…