GSK’s daprodustat, which is sold under the brand name Jesduvroq, has been granted class-first approval following two previous FDA rejections for oral anemia medications in the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class. The drug is specifically approved for the treatment of chronic kidney disease patients with anemia who have been on dialysis for at least four months.
The FDA concluded that the drug’s safety has not been established in that population, despite GSK’s efforts to obtain approval to treat patients who do not require dialysis.
Jesduvroq belongs to a class of drugs that hasn’t done well in the past. Medicines from Akebia Therapeutics, Otsuka, AstraZeneca, and Fibrogen, in addition to AstraZeneca and Fibrogen, have already been rejected by the FDA, largely due to safety concerns. AZ and Fibrogen’s treatment were linked to an increased risk of death, blood clots, serious infections, and more safety concerns, while Akebia and Otsuka’s treatment was cited as having a higher risk of liver injuries and blood clots.
The FDA noted in its pre-advisory briefing document in October that Jesduvroq’s safety risks in the non-dialysis-dependent patient population included elevated risks for heart attack and stroke. The advisory committee was hesitant about this because approved erythropoiesis-stimulating agents already carry risks similar to this one.
Additionally, the dialysis patient population posed safety risks. A boxed warning will be included with Jesduvroq, highlighting the increased risk of blood clotting events such as death, heart attack, stroke, and blood clots in the lungs, legs, or the dialysis access site.