GSK Receives FDA Approval for Drug Treatment of Anemia of Chronic Kidney Disease - MedCity NewsGSK Receives FDA Approval for Drug Treatment of Anemia of Chronic Kidney Disease - MedCity News

Anemia caused by chronic kidney disease can be treated with injectable drugs, but various pharmaceutical industry players are pursuing alternatives that offer patients the convenience of a single pill. GSK’s drug won FDA approval as the first pill in the drug class, a decision that comes after the agency rejected applications from two other contenders.

The approval of the GSK drug daprodustat, brand name Jesduvroq, covers only adults who have been on dialysis for at least four months, a narrower patient population that is followed with recommendation to an FDA advisory committee last October. Although these advisers supported approval in dialysis patients, they voted against the drug’s use in those not on dialysis, saying the risks did not outweigh the benefits in this group of patients. The Jesduvroq label carries a black box warning stating that the drug’s potentially fatal cardiovascular risks include heart attack, stroke and blood clots in the lungs, legs or dialysis access site.

According to the FDA, more than half a million adults in the U.S. have chronic kidney disease that requires dialysis. In such patients, the kidneys are unable to produce enough erythropoietin, a hormone that signals the body to produce red blood cells. Low levels of erythropoietin lead to anemia. Available treatments include erythropoietin-stimulating agents (ESAs), drugs that are engineered versions of erythropoietin. But these injectable drugs must be administered regularly in clinical settings—a burden on patients and their caregivers.

Jesduvroq is designed to block hypoxia-inducible factor prolyl hydroxylase (HIF-PH). Blocking these enzymes stabilizes hypoxia-inducible factors, proteins that play a role in the body’s response to low oxygen levels. In low-oxygen conditions, the body produces more erythropoietin to stimulate the production of more oxygen-carrying red blood cells. HIF-PH inhibitors trigger this activity through small molecules formulated as pills.

The FDA’s approval of Jesduvroq was based on the results of a phase 3 study involving 2,964 patients who were on dialysis. The GSK drug increased hemoglobin levels and maintained them in a range comparable to levels in patients treated with ESO. The most common side effects reported from the trial included high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions. The results of the experiment were published in 2021 in the New England Journal of Medicine.

“There has been little innovation in anemia over the past few decades [chronic kidney disease]GSK President and Chief Scientific Officer Tony Wood said in a prepared statement. “We are proud to have developed Jesduvroq as a new oral treatment where there is a patient desire for more options.”

Other companies have advanced HIF-PH inhibitors through basic research, only to fall short of the FDA. In 2021, the FDA rejected FibroGen’s roxadust, a drug previously approved in China, Japan, Chile and South Korea. In March last year, the agency rejected Akebia Therapeutics’ vadadustat drug and requested another clinical trial to show that its benefits outweigh the safety risks. It’s Akebia attractive the FDA’s rejection of vadadustat, a drug approved in Japan and under regulatory review in Europe.

Jesdurock was first approved in 2020 in Japan, where it is marketed as Duvroq. The GSK drug is currently under review in Europe; a regulatory decision there is expected in the first half of this year.

Photo by GSK

Source link

Leave a Reply

Your email address will not be published. Required fields are marked *