GSK PLC (LSE:GSK, NYSE:GSK) has reported that a US Food and Drugs Administration (FDA) committee voted that the benefits of its drug, daprodustat outweighed risks for adult dialysis patients with anaemia of chronic kidney disease (CKD), but not for those not undergoing dialysis.
The company said the FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 13 to three in favour of saying the drug benefitted patients on dialysis, but five to 11 against for non-dialysis patients.
After phase three clinical trials, which saw over 8,000 patients treated for up to four years with daprodustat, GSK submitted a new drug application (NDA) in April, which the FDA continues to consider approval for, with the vote being part of this process.
In its statement, the FDA said it will consider the vote, feedback, and recommendations from the CRDAC as it reviews the NDA and is not bound by the committee's recommendation
CKD, which sees the progressive loss of kidney function, affects 700mln people worldwide, with one in seven of these patients also developing anaemia.
In a statement, Chris Corsico, senior vice president at GSK said: "Today's robust discussion was an important step in the review of daprodustat. We are pleased the committee recognised the potential for daprodustat to help certain patients who are living with anaemia of CKD given limited treatment options.”
GSK shares were up 1.4% to 32p in early trade on Thursday.