FDA greenlights Jesduvroq, which GSK hails as ‘first innovative medicine’ for anemia in three decades

GSK (NYSE:GSK) has received FDA approval for Jesduvroq, an oral 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…

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