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Regulatory Focus™ > News Articles > 2019 > 7 > FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation

FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation

Posted 26 July 2019 | By Zachary Brennan 

FDA Finalizes Guidance on Delayed Graft Function in Kidney Transplantation

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draft and final guidance, FDA said in the Federal Register that it “considered the few public comments received on the draft guidance and appropriate changes were made, including a rationale for the recommended number of patients for a preapproval safety database.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.

“If the same or greater dose and duration of therapy for the prevention of DGF were used in clinical trials for other disease indications, the safety information from those clinical trials can be part of the overall preapproval safety database,” the guidance says.

And the agency also explains how some new drugs that have an important clinical benefit, depending on what’s demonstrated, may be able to use a smaller preapproval safety database. Discussions with FDA on the appropriate size of the preapproval safety database should continue through clinical development, the agency adds.

In addition, the guidance explains how the accelerated approval pathway works with confirmatory postmarket data and notes: “While a primary endpoint that includes prevention of hemodialysis treatment during the first 7 days post-transplant is associated with clinical benefit and could be used to support a traditional approval, sponsors should discuss with the FDA plans to use any surrogate endpoints that are reasonably likely to predict clinical benefit to support accelerated approval.”

The guidance also discusses efficacy endpoints, statistical considerations and risk-benefit considerations.

Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention: Guidance for Industry

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