GSK Submits First Global Regulatory Application for HIF-PH Inhibitor Daprodustat in Japan for Renal Anemia
Aug 23, 2019 08:59
CST Updated
08:59
GSK
Pharmaceutical R&D Manufacturer
Ministry of Health, Labour and Welfare
The Ministry of Health, Labour and Welfare is a cabinet-level ministry of the Japanese government. It is commonly known in Japan as the Kōrō-shō. The ministry provides health, labor, and welfare services.
August 23, 2019 /BioValleyBIOON/ -- British pharmaceutical giantGlaxoSmithKline(GSK) recently announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW), seeking approval for the oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) daprodustat for the treatment of renal anemia caused by chronic kidney disease (CKD).Anemia。
The New Drug Application (NDA) for daprodustat is primarily based on positive data from Phase III clinical trials conducted in Japan. These studies evaluated the efficacy of daprodustat in treating anemia in patients with Stage 3–5 chronic kidney disease, including both dialysis-dependent and non-dialysis-dependent patients, regardless of prior treatment with erythropoiesis-stimulating agents (ESAs) for anemia.
In November 2018, GSK and Kyowa Kirin Co., Ltd. signed a strategic collaboration agreement for the future commercialization of daprodustat in the Japanese market. Under the terms of the agreement, GSK will be responsible for completing the Phase III clinical program and submitting regulatory filings for approval in Japan. Following regulatory approval, Kyowa Kirin will have exclusive responsibility for the distribution of daprodustat in the Japanese market.
In addition to the clinical program in Japan, GSK is conducting a global Phase III registration program comprising two Phase III studies that evaluate daprodustat for the treatment of anemia in patients with dialysis-dependent chronic kidney disease (the ASCEND-D study) and non-dialysis-dependent chronic kidney disease (the ASCEND-ND study), respectively. The results of these two studies are expected to be available in 2020.
Dr. Hal Barron, Chief Scientific Officer and President of Research and Development at GSK, stated, “Approximately 3.5 million patients in Japan suffer from anemia associated with kidney disease, which leads to weakness and fatigue. We are delighted to submit the first global regulatory filing for daprodustat, which, if approved, will provide these patients with a new, convenient oral treatment option.”
Molecular Structure of Daprodustat (Image Source: selleck.cn)
Anemia is common in patients with chronic kidney disease (CKD), as their kidneys no longer produce sufficient amounts of erythropoietin, a hormone involved in promoting red blood cellGenerated hormones. Daprodustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that inhibits oxygen-sensing prolyl hydroxylase (PH), thereby stabilizingStabilizing hypoxia-inducible factor (HIF) leads to the transcription of erythropoietin and other genes involved in erythropoiesis and iron metabolism, which is similar to the human body's response at high altitudes.Physiological effects occurring within.
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 treating renal anemia.patients benefit.Daprodustat will provide a convenient oral treatment option, avoiding the administration challenges and refrigeration requirements associated with injectable erythropoiesis-stimulating agents (ESAs)/recombinant human erythropoietin.
It is worth mentioning that, just recently,AstraZenecaPartner FibroGen China’s anemia drug roxadustat (brand name: Evrenzo®) has received approval from China’s National Medical Products Administration (NMPA) for a new indication: the treatment of anemia in patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). This approval marks the first expansion of roxadustat’s indications since its initial approval on December 17, 2018, for treating anemia in dialysis-dependent chronic kidney disease patients. As a global first-in-class innovative drug, roxadustat has pioneered comprehensive application in China for both dialysis-dependent and non-dialysis-dependent CKD patients with anemia, delivering a novel therapeutic breakthrough for the broad population of Chinese patients with chronic kidney disease.
Roxadustat is the world’s first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), jointly developed by AstraZeneca and FibroGen. As the first Class 1 new drug to undergo simultaneous global development with its initial launch in China, Roxadustat was included in China’s National Major Science and Technology Project for “Major New Drug Development.” Benefiting from strong government support for pharmaceutical innovation and deepened reforms in drug review and approval, Roxadustat received priority review from the China National Medical Products Administration and was scheduled for full market launch in China in the second half of 2019. (Bioon.com)