GlaxoSmithKline’s Jesduvroq (daprodustat) has earned a class-first approval by the FDA after suffering two rejections in the HIF-PHI (hypoxia-inducible factor prolyl hydroxylase inhibitor) drug class for the oral anemia drugs.
The approval is only for those anemia patients in whom the problem is caused by chronic kidney disease. Another prerequisite for Jesduvorq use is that the patient should be on dialysis for a minimum of four months.
The company was hoping for approval for the treatment of patients that do not require dialysis. However, the FDA said that the drug’s safety is not certain and cannot be confirmed for that population. This does not come as a shock as the FDA advisory committee that met in October for the drug’s endorsement had only recommended the drug for patients that were dependent on dialysis.
Jesduvroq’s drug class has not been successful in the past and the FDA has previously rejected numerous big brand names on the grounds of safety. Such rejected medicine include those from AstraZeneca, Akebia Therapeutics and Otsuka, and Fibrogen. Akebia and Otsuka’s drug was linked to greater risks of liver injuries and blood clots, while Fibrogen and AstraZeneca were both associated with higher risks of serious infections, blood clots, or even death.
The Chief Commercial Officer of GSK Luke Miels stated recently that the company’s strategy in terms of commercialization will be focusing on dialysis providers for the treatment. He also said that for the time being, the company will not be running further trials in an attempt to gain the non-dialysis population.
According to a pre-advisory document dating back to October, the FDA noted that Jesduvroq had projected high risks for a stroke and heart attack in clinical trials for patients that were not dependent on dialysis. The advisory committee became hesitant after this information was revealed as erythropoiesis-stimulating agents come with such risks already.
There were safety risks observed in the dialysis-dependent population as well, but none was considered to be big enough to become a barrier to approval. However, Jesduvroq will come with a boxed warning that will accentuate the amplified risk of blood clotting events like stroke, heart attack, death, or clots in the legs or lungs.
Nearly 700M patients are affected by CKD (chronic kidney disease) in the world while approximately one in 7 such patients develop anemia. Talking about the advisory committee’s decision, GSK noted that if not treated, or not treated properly, Anemia of CKD could lead to significant problems for both the patient and the healthcare systems.
Along with the announcement of the fourth quarter results, the company mentioned that there is a need for more convenient medication options that are effective as well as safe. Other treatments that are available can only be given as injectables.
The company mentioned that its drug is the leader in the Japanese market and the preferred member of the HIF-PHI class. However, in that market, it goes by the name Duvroq and is available for the treatment of patients who suffer from renal anemia as a result of CKD.