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GSK secures FDA approval of anemia drug, but with limitations

February 2, 2023


Jesduvroq belongs to a new class of oral treatments that GSK, along with rivals FibroGen and Akebia Therapeutics, saw as more convenient alternatives to the injectable medicines that are currently standard for treating kidney disease-related anemia. But in August 2021 and then again in March last year, the FDA rejected Fibrogen’s and Akebia’s therapies over safety concerns, dimming the drug class’ potential.

The drugs, called HIF-PH inhibitors, work by tricking the body into responding as if it is in a high-altitude environment, spurring production of a hormone called erythropoietin. Higher erythropoietin production leads to increased levels of red blood cells, treating patients’ anemia.

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