A small but notable win for GSK with daprodustat
Safety concerns have diminished the commercial outlook for HIF-PH inhibitors, a novel class of oral anaemia drugs once touted as blockbusters in waiting. Of the global regulators the FDA has proved the most cautious, so a green light for GSK’s daprodustat is a notable win for the developer, which can now boast of having the only HIF-PHI on the US market. As expected the drug, now branded Jesduvroq, was approved only in kidney disease patients already on dialysis; the FDA said safety in pre-dialysis populations had not been established. This echoes the thoughts of last year's advisory committee, which was primarily concerned about the heart failure risk in this population and recommended further studies. GSK declined to say whether it would try again in this potentially larger patient group; given the time and cost involved it seems unlikely. European and Japanese regulators approved Astellas’s Evrenzo in both groups – GSK expects EU approval in the coming months, and a broad label here is also likely. The big question now is whether Astrazeneca, which owns US rights to Evrenzo, will try again with the FDA, now that the agency has shown it is not completely against the idea of this class.