GSK's HIF-PH Inhibitor Duvroq (Daprodustat) Receives Partial Support from FDA Advisory Committee for Renal Anemia Treatment

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October 28, 2022 /BioValleyBIOON/ -- GlaxoSmithKline (GSK) recently announced that the U.S. Food and DrugManagementBureau (FDA) HeartBlood VesselAnd the Cardio-Renal Drug Advisory Committee (CRDAC)The voting result of 13 votes in favor and 3 votes against supports that the benefits of Duvroq (daprodustat, tablets) for the treatment of anemia in adult patients with chronic kidney disease (CKD) on dialysis outweigh the risks.. However, CRDACWith a vote of 5 in favor and 11 against, the benefits of using Duvroq for treating anemia in non-dialysis CKD adult patients were not considered to outweigh the risks.。

The US FDA will consider the CRDAC's vote, feedback, and recommendations when reviewing a New Drug Application (NDA), but is not bound by the committee’s advice. CRDAC provides independent expert opinions to the US FDA, reviewing and evaluating existing data on the safety and efficacy of marketed and potential new drugs for the treatment of cardiovascular and renal diseases. In April 2022, the US FDA accepted the NDA for daprodustat and set the target date under the Prescription Drug User Fee Act (PDUFA) as February 1, 2023.

CKD is an increasingly serious global health burden, affecting 700 million patients worldwide. It is estimated that one in every seven CKD patients also develops anemia, leading to increased morbidity and mortality.Quality of LifeReduce.In some CKD patients, if not managed adequately, anemia may lead to exhaustion and limit functional capacity in daily life.If left untreated or inadequately treated, CKD anemia can lead to adverse clinical outcomes., and impose a significant burden on patients and the healthcare system. There remains an unmet need for convenient treatment options that offer efficacy and safety comparable to current therapies.

GSK Senior Vice President of Development Chris Corsico stated, "Today's robust discussion is an important step in the review of daprodustat. We are pleased that the committee recognized the potential of daprodustat to help certain CKD anemia patients with limited treatment options. We would like to thank the doctors, patients, and advocacy groups who have shared valuable insights on this condition. We look forward to continuing our collaboration with the U.S. FDA to complete the review of our new drug application."

Anemia is common in patients with chronic kidney disease (CKD)., because the kidneys of such patients no longer produce a sufficient amount of erythropoietin, a hormone involved in promoting red blood cell production.Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).Inhibition of oxygen-sensing prolyl hydroxylase (PH) can stabilize hypoxia-inducible factor (HIF), leading to the transcription of erythropoietin and other genes involved in erythropoiesis and iron metabolism, which is similar to the physiological effects that occur in the human body at high altitudes.HIF-PHI is a new class of drugs that can trigger the body's adaptation to hypoxia and stimulate the bone marrow to produce more red blood cells, thereby benefiting patients with renal anemia.

Daprodustat was studied in the ASCEND Phase 3 program. This program consisted of five Phase 3 clinical trials evaluating the efficacy and safety of daprodustat in treating anemia due to CKD across the spectrum of CKD. The program enrolled over 8,000 patients who received treatment for up to 4.26 years. Data from the program showed,Daprodustat met the primary efficacy endpoint in all five pivotal trials.: Improved hemoglobin (Hb) levels in untreated CKD anemia patients and maintained Hb levels in CKD anemia patients treated with erythropoiesis-stimulating agents (ESA, a standard treatment option). Additionally, two key cardiovascular outcome studies in non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients showed that daprodustat, compared with ESA, met the co-primary endpoints of major adverse...Cardiovascular Events(MACE) risk showed non-inferiority.

Duvroq was approved in Japan in June 2020 for the treatment of renal anemia in adult patients caused by CKD.. This is the world's first regulatory approval for Duvroq, which has not yet been approved in other regions globally. In November 2018, Kyowa Kirin and GSK signed a commercial strategic cooperation agreement for Duvroq in the Japanese market. According to the terms of the agreement, after obtaining regulatory approval, Kyowa Kirin will be fully responsible for the distribution of Duvroq in the Japanese market.

Duvroq can reduce renal anemia and benefit patients by stimulating the bone marrow to produce more red blood cells.This medication offers a convenient oral treatment option, avoiding the administration challenges and refrigeration requirements associated with injectable erythropoiesis-stimulating agents/recombinant human erythropoietin (rhEPO). In addition, Duvroq can be used in both dialysis and non-dialysis patients, providing a more convenient treatment alternative for renal anemia. (Bioon.com)

Source of the original text:GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD