GSK's Oral HIF-PHI Jesduvroq Receives Positive CHMP Opinion for Anemia in CKD Patients on Dialysis
GSK
Pharmaceutical R&D Manufacturer
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
智通财经APP获悉，葛兰素史克（GSK.US）周一表示，欧洲药品管理局（EMA）的人用药委员会（CHMP）发布了一项积极意见，建议批准其口服缺氧诱导因子脯氨酰羟化酶抑制剂（HIF-PHI）Jesduvroq（daprodustat，中文译名：达普司他）作为治疗慢性肾脏病（CKD）引起的贫血的药物，适用于长期接受透析的成人患者。
Data shows that daprodustat, by inhibiting PH-HIF, can lead to the transcription of erythropoietin and other genes involved in erythropoiesis and iron metabolism, thereby promoting red blood cell synthesis. The drug was first approved in Japan in 2020. In February this year, the drug received approval from the U.S. Food and Drug Administration (FDA) as the first oral treatment for anemia caused by chronic kidney disease (CKD), applicable to adult patients undergoing dialysis for at least four months, but it has not been approved for patients not undergoing dialysis.