U.S. FDA approves GSK’s anemia drug for CKD patients on dialysis

UNITED KINGDOM — The U.S. FDA has approved GlaxoSmithKline’s (GSK) Jesduvroq (daprodustat) for the treatment of anemia caused by chronic kidney disease (CKD) in adults who have been on dialysis for at least four months.

Chronic kidney disease (CKD) affects 700 million patients worldwide, with an estimated 1 in 7 patients developing anemia.

Anemia of CKD, left untreated or undertreated leads to “a substantial burden” on both patients and healthcare systems, GSK noted in a statement discussing the advisory committee’s decision.

Jesduvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). HIF-PH inhibitors are a class of oral drugs designed to boost production of red blood cells by mimicking the body’s response at high altitudes, where a lack of oxygen leads to increase in red cell numbers and hemoglobin concentration.

It is claimed to be the only HIF-PHI approved in the country, providing a new oral treatment option for adult dialysis patients with CKD anemia.

The approval is GSK’s first since it spun off its consumer health business, which includes Sensodyne toothpaste and Advil pain relievers, last year.

The decision comes after the health agency’s advisory committee recommended the treatment for some kidney patients in October.

Jesduvroq belongs to a class of drugs that hasn’t had a lot of success in the past. The FDA has already rejected drugs from Akebia Therapeutics and Otsuka, as well as AstraZeneca and Fibrogen, citing safety concerns.

Higher risks of blood clots and liver injuries were cited as safety concerns for Akebia and Otsuka’s treatments, whereas AstraZeneca’s and Fibrogen’s treatments were linked to an increased risk of death, blood clots, serious infections, and other complications.

Jesduvroq is labeled with a boxed warning for an increased risk of thrombotic vascular events, such as death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site.

The risks of hospitalization for heart failure, worsening blood pressure, stomach erosions, and gastrointestinal bleeding are also mentioned in the warnings and precautions.

The FDA stated that the treatment is not approved for patients who are not on dialysis because its safety has not been established in that population.

GSK’s treatment will be commercialized through contracts with dialysis providers, according to GSK’s chief commercial officer Luke Miels as reported by Fierce Pharma.

Miels stated at the time that the company would not conduct additional trials to try again for the non-dialysis population.

According to the company’s fourth-quarter results announcement, there is still an unmet need for convenient treatment options with comparable safety and efficacy to current treatments. Other treatments are available in the form of injections.

According to GSK, the drug is the market leader and preferred HIF-PHI class member in Japan. It is approved as Duvroq in the United States to treat patients with renal anemia caused by CKD.

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