近些年来,FDA鲜有批准抗疟疾新药。2018年7月20日,FDA批准了葛兰素史克的他非诺喹(Tafenoquine),用于正在接受适当抗疟药物治疗急性间日疟原虫感染的16岁及以上疟疾患者,根治由间日疟原虫导致的疟疾,另外FDA为嘉奖GSK在热带病药品研发方面的贡献,给予其一张优先审评劵。 药物简介 英文名:Tafenoquine 中文名:他非诺喹 ...
据"中国医药报"5月19日报道,葛兰素史克(GSK)和非营利组织"抗疟药品事业会"(MMV)近日宣布,启动一项全球Ⅲ期项目,以评估他非诺喹(tafenoquine)用于间日疟治疗及预防复发(根治)的疗效和安全性。美国食品药品管理局(FDA)于2013年12月给予tafenoquine突破性疗法认定,目前该药尚未获得任何监管部门批准。该Ⅲ期临床项目...
The SIL approach was successfully implemented to enable the setting of a clinically relevant dissolution specification. Clinical trial: This study (GSK study number 201780) is registered at clinicaltrials.gov with identifier NCT02751294.Similar content being viewed by others Comparative Bioavailability of ...
伯氨喹是上世纪50年代研制的药物,他非诺喹与伯氨喹的化学结构相似,同为8-氨基喹啉类药物。沃尔特·里德陆军研究所(Walter Reed Army Institute of Research)的科学家于1978年首次发现tafenoquine,该药由葛兰素史克(GlaxoSmithKline, GSK)与疟疾药物理事会(Medicines for Malaria Venture, MMV)联合开发2018年陆续完成临床...
readily available drugs,such as chloro-quine and sulfadoxine-pyrimethamine that are commonly used to treat it.Newer medicines,such as the artemisenin based combination therapies and GSK's newly approved LapDap are much more effective,but the need for additional therapies to combat resistant ...
GSK and MMV announce start of phase III programme of tafenoquine for Plasmodium vivax malaria - European Pharmaceutical Review
Sharma and colleagues at the pharmaceutical company GSK defend the currently recommended adult dose of 300 mg as the optimum balance between radical curative efficacy and haemolytic toxicity (Sharma et al., 2024). We contend that the relative haemolytic risks of the 300 mg and 4...