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艾尔健(Allergan)公司近日在欧盟监管方面传来喜讯,欧盟委员会(EC)已批准该公司药物Truberzi(eluxadoline)用于腹泻型肠易激综合征(IBS-D)患者的治疗。此次批准,使Truberzi成为欧洲IBS-D群体中首个治疗药物。艾尔健公司表示,将在2017年将产品推向欧洲市场。Truberzi的获批,是基于2项关键性III期临床研究的积极数据。数据显示,Truberzi显著降低了腹泻型肠易激综合征2种使临床医师治疗棘手的症状,即腹部疼痛与腹泻,持续缓解时间达6个月以上。安全性方面,Truberzi的耐受性良
Allergan recently delivered good news on EU regulation. The European Commission (EC) has approved the company’s drug Truberzi (eluxadoline) for the treatment of patients with diarrhea-predominant irritable bowel syndrome (IBS-D). This approval makes Truberzi the first treatment in the European IBS-D community. Elgin said it will push its products to the European market by 2017. Truberzi’s approval is based on positive data from two pivotal Phase III clinical studies. The data showed that Truberzi significantly reduced diarrhea-predominant irritable bowel syndrome (2) to enable clinicians to treat intractable symptoms of abdominal pain and diarrhea with sustained remissions lasting more than 6 months. In terms of safety, Truberzi is well tolerated