RedHill Biopharma宣布FDA批准Talicia用于治疗成人幽门螺旋杆菌感染

2019-11-04 不详 MedSci原创

Talicia是获批的唯一基于利福布汀治疗幽门螺杆菌感染的疗法,旨在解决幽门螺杆菌对当前基于克拉霉素的护理标准疗法的高耐药性。据估计,幽门螺杆菌对克拉霉素的耐药性在2009-2013年之间翻了一番以上。

RedHill计划于2020年第一季度在美国推出Talicia,用于治疗幽门螺旋杆菌感染的成年人,目标预计为每年治疗超过两百万幽门螺旋杆菌感染患者。

Talicia(奥美拉唑镁,阿莫西林和利福布汀,10毫克/ 250毫克/ 12.5毫克)延迟释放胶囊是一种新型固定剂量,两种抗生素(阿莫西林和利福布汀)功能于一身的口服胶囊组合,经美国FDA批准用于治疗成人幽门螺杆菌感染的质子泵抑制剂(PPI)(奥美拉唑)。为了减少耐药菌的产生并保持Talicia和其他抗菌药物的有效性,Talicia仅应用于治疗或预防已证明或强烈怀疑由细菌引起的感染。

幽门螺杆菌感染了大约35%的美国成年人口,被列为第一类致癌物,是发生消化性溃疡,炎和非心脏性癌的最强危险因素。

Talicia是获批的唯一基于利福布汀治疗幽门螺杆菌感染的疗法,旨在解决幽门螺杆菌对当前基于克拉霉素的护理标准疗法的高耐药性。据估计,幽门螺杆菌对克拉霉素的耐药性在2009-2013年之间翻了一番以上。

休斯顿贝勒医学院的医学博士David Y. Graham教授说:"Talicia为患者提供了急需的新方法,治疗幽门螺杆菌具有出色的安全性和有效性,不受克拉霉素或甲硝唑耐药性的影响。对Talicia的临床研究表明,它可有效根除幽门螺杆菌,对利福布丁的耐药性为零,对克拉霉素的耐药性为17%,目前的护理标准大环内酯类抗生素,与目前的数据一致,表明含有克拉霉素的疗法在大约25-40%的病例中无效。"

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    2020-03-30 sunylz
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    2019-11-10 jj000001
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    2020-03-28 andy2100
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    2020-02-14 bugit

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RedHill制药今日表示,针对克罗恩病患者的实验性药物RHB-104的III期研究符合其主要终点,以及关键的次要终点。首席执行官Dror Ben-Asher表示:“我们期待与FDA讨论RHB-104的审批之路,并加快与潜在制药合作伙伴的讨论”。