Adcomm offers mixed voice, recommends GSK’s kidney disease drug in just one patient population – Endpoints News
Just days after the FDA raised safety concerns about a kidney disease candidate from GSK, the company didn’t end up getting all the green lights from an adcomm.
The FDA’s Cardiovascular and Renal Drugs Advisory Committee met over daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor once hailed by former R&D chief Hal Barron as a top chronic kidney disease drug in the drugmaker’s late-phase pipeline. The FDA, as of Tuesday, raised some questions about whether the benefits were worth it, given some of the potential risks. Those risks, according to the agency, would have included heart failure and gastric erosion, plus heart attack and stroke risk in a more specific subset of patients.
Japan’s health authority approved the drug earlier this year, and the drug is on the doorstep of the EU.
Fast forward to adcomm, and after more than nine hours of deliberation, the FDA panel came away with recommending the drug for dialysis patients and voting against the drug in patients not dependent on the procedure.
The FDA’s final word is expected by February 1. Which path the agency will follow is still unclear — although the FDA is not required to follow the committee’s advice, it usually does.
On the first question: The Committee of 16, when asked “Do the benefits of daprodustat outweigh the risks for the treatment of anemia due to CKD in adults not on dialysis?” voted 5 for and 11 against.
One of the committee members, Afshin Parsa of the University of Maryland School of Medicine, voted “yes” but conceded in his reasoning that while there are “potential concerns about increased risk,” many of those concerns can be addressed, he said. “Administered by healthcare professionals or patients as long as appropriate educational and other safety precautions are in place,” Parsa added.
C. Noel Bairey Merz of Cedars Sinai said no.
“I felt that we met the primary outcome – it’s not inferior to the primary outcome – but while I don’t think we feel confident that there is an increased risk, the data we heard today makes us uncertain about the increased risk.. “I think we need more information about the risk,” he said.
About 30 minutes later, committee members were asked, “Do the benefits of daprodustat outweigh the risks for treating anemia due to CKD in adults on dialysis?” This time the committee agreed, and voted 13-3.
“In this patient population, the effect was met,” said Christopher O’Connor of the Inova Heart and Vascular Institute, one of the “yes” votes. “I felt the safety signals in the cardiovascular space seemed more favorable than the ESA.” He added that the patients had to be closely monitored while being treated.
Javed Butler of the University of Mississippi’s Medical Center was not so convinced of the benefit.
“Looking at the totality of the evidence across these two patient populations … the way the cardiac data was collected, as well as other data, was of concern to me,” he said. “In terms of the benefit, I wasn’t completely convinced of the use case for the benefit of these patients.”
GSK’s senior development manager Chris Corsico told News about endpoints in a statement that “Today’s robust discussion was an important step in the review of daprodustat. We are pleased that the committee recognized the potential for daprodustat to help certain patients living with the anemia of CKD given limited treatment options. We would like to thank doctors, patients and the legal community who shared their valuable insights about this disease. We look forward to continuing to work with the US FDA as they complete their review of our new drug application.”