GSK (NYSE:GSK) has received FDA approval for Jesduvroq, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), as a daily treatment for anemia associated with chronic kidney disease in adult dialysis patients.
Jesduvroq is the first new medicine for anemia treatment in over 30 years, GSK noted.
The drug is the only HIF-PHI to win FDA approval.
Black box warning
A black box warning, however, may constrain its use. The warning notes that Jesduvroq may lead to an increased risk of death, heart attack and other cardiovascular problems. In addition, the warning notes that the drug may elevate the risk of blood clotting problems and major heart events. The FDA recommends that the drug be used only at the lowest dose to minimize the need for blood transfusions.
Barclays estimated Jesduvroq sales to top out at £364 million ($450 million).
GSK shares ticked down one percentage point to $35.13 after announcing the approval news.
HIF-PHIs offer promise for correcting anemia
HIF-PHIs target prolyl hydroxylase enzymes that regulate the hypoxia-inducible factors (HIFs) pathway. Inhibiting these enzymes stabilizes HIFs and promotes gene transcription in correcting anemia.
A report in the journal Kidney noted that HIF-PHIs show promise in maintaining hemoglobin levels in patients with both non-dialysis- and dialysis-dependent CKD.
FDA based on the Jesduvroq approval on data from the pivotal ASCEND-D study.
The trial found that Jesduvroq was non-inferior to erythropoiesis-stimulating agents regarding the change in hemoglobin level from baseline and cardiovascular outcomes.
CKD affects around 700 million patients worldwide, with an estimated one in seven developing anemia.
In October 2022, GSK announced that FDA’s Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted in favor of daprodustat in adult dialysis patients with anemia of CKD with a 13 to 3 vote. However, the committee did not recommend the drug for adult non-dialysis patients with anemia of CKD.
Jesduvroq is currently under review with the European Medicines Agency, with a decision expected in 2023.
Filed Under: Nephrology/urology