GSK Announces Complete Success of All Five Phase 3 ASCEND Studies for Duvroq (Daprodustat) in Renal Anemia
Jul 18, 2021 01:59
CST Updated
01:59
GSK
Pharmaceutical R&D Manufacturer
Erythropoiesis (Image source: ncyclopedia.lubopitko-bg.com)
July 18, 2021 /BioonBIOON/ ---GlaxoSmithKline(GSK) recently announced positive top-line results from five clinical trials in the Phase 3 ASCEND program. These trials are evaluating Duvroq (daprodustat tablets)Treatment of renal ... caused by chronic kidney disease (CKD)Anemia。Duvroq is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI).
Data from the ASCEND trial show that,Daprodustat met the primary efficacy endpoint in each study.：improved hemoglobin (Hgb) levels in patients with untreated CKD anemia and maintained Hgb levels in patients with CKD anemia receiving erythropoiesis-stimulating agents (ESAs, a standard treatment option). Furthermore, two pivotal cardiovascular outcome studies in non-dialysis patients (ASCEND-ND) and dialysis patients (ASCEND-D) demonstrated that:Compared with ESA, daprodustat demonstrated non-inferiority for the risk of major adverse cardiovascular events (MACE) at the co-primary endpoint.
Dr. Hal Barron, GSK’s Chief Scientific Officer and President, Research and Development, stated: “I am particularly pleased with the results of the ASCEND-ND and ASCEND-D studies, as managing cardiovascular outcomes is critically important for patients currently experiencing anemia due to chronic kidney disease (CKD), and there is a clear need to provide a convenient oral treatment option. We will continue to analyze the robust data from the Phase 3 ASCEND program and look forward to working closely with regulatory authorities during the submission of marketing authorization applications.”
In addition to the ASCEND-D and ASCEND-ND studies, the program also includes an incident dialysis study for patients newly initiating dialysis (ASCEND-ID), a quality of life measurement study (ASCEND-NHQ), and a thrice-weekly dosing regimen study (ASCEND-TD). Each study within the program met its respective primary or co-primary endpoint(s). The program enrolled over 8,000 patients, who received treatment for up to 3.75 years. The complete results of these studies will be presented at medical conferences later this year.Meetingpublished, and will be used to inform regulatory authorities worldwide of regulatory pathways.
Throughout the ASCEND program,Daprodustat was well tolerated in both non-dialysis and dialysis patients.The incidence of treatment-emergent adverse events (TEAEs) was similar across treatment groups. Throughout the ASCEND program, the most common adverse events in patients treated with daprodustat includedHypertension, diarrhea, intradialytic hypotension, peripheral edema, and urinary tract infection.
Chemical structure of daprodustat (Image source: selleck.cn)
Anemia is common in patients with chronic kidney disease (CKD) because their kidneys no longer produce sufficient erythropoietin, a hormone involved in promoting erythropoiesis. Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI). Inhibition of oxygen-sensing prolyl hydroxylase (PH) stabilizes hypoxia-inducible factor (HIF), leading to the transcription of erythropoietin and other genes involved in erythropoiesis and iron metabolism, which mimics the physiological effects that occur in the human body at high altitudes.
HIF-PHIs are a new class of drugs that trigger the body's adaptive response to hypoxia and stimulate the bone marrow to produce more red blood cells, thereby benefiting patients with renal anemia.
Duvroq was approved in Japan in June 2020 for the treatment of renal anemia in adult patients caused by chronic kidney disease (CKD). This marks the first global regulatory approval for Duvroq; the drug has not yet been approved in other regions. In November 2018, Kyowa Kirin and GSK entered into a strategic partnership agreement for the commercialization of Duvroq in the Japanese market. Under the terms of the agreement, Kyowa Kirin assumes full responsibility for the distribution of Duvroq in Japan following regulatory approval.
Duvroq reduces renal anemia and benefits patients by stimulating the bone marrow to produce more red blood cells. This drug offers a convenient oral treatment regimen that avoids the administration challenges and refrigeration requirements associated with injectable erythropoiesis-stimulating agents/recombinant human erythropoietin (rhEPO). Furthermore, Duvroq can be used in both dialysis and non-dialysis patients, providing a more convenient therapeutic option for the management of renal anemia. (Bioon.com)