IPSEN类癌综合征腹泻药物Xermelo获欧盟批准

2017-09-21 佚名 新浪医药新闻

IPSEN近日宣布,欧盟委员会已经批准了每日三次250 mg剂量的Xermelo药物联合生长抑素类似物(SSA)用于类癌综合征腹泻在成人不充分控制的SSA治疗。该批准将允许IPSEN在欧盟、挪威和冰岛等28个成员国中销售Xermelo。2017年2月,美国FDA批准Xermelo与生长抑素类似药联合用于成年患者类癌综合征腹泻治疗,适用于仅使用生长抑素类似药治疗疾病得不到控制的患者。


IPSEN近日宣布,欧盟委员会已经批准了每日三次250 mg剂量的Xermelo药物联合生长抑素类似物(SSA)用于类癌综合征腹泻在成人不充分控制的SSA治疗。该批准将允许IPSEN在欧盟、挪威和冰岛等28个成员国中销售Xermelo。2017年2月,美国FDA批准Xermelo与生长抑素类似药联合用于成年患者类癌综合征腹泻治疗,适用于仅使用生长抑素类似药治疗疾病得不到控制的患者。

类癌瘤综合征是在类癌瘤患者中偶尔见到的一组症状。这些肿瘤比较罕见,且增长缓慢。大多数类癌瘤发现于胃肠道。类癌瘤综合征通常在不到10%的类癌瘤患者中出现,往往在肿瘤扩散至肝脏后发生。这些患者的肿瘤会释放过多的血清素,从而导致腹泻。无法控制的腹泻综合征包括体重下降、营养不良、脱水及电解质紊乱。

Ipsen首席执行官David Meek说:“我们很高兴可以结合结合生长抑素类似物,为类癌综合征控制不佳的患者提供一种新的治疗方案,该疗法可以显著改善腹泻的,具有良好的疗效和安全性。 Xermelo?补充了我们的神经内分泌肿瘤策略,旨在在患者治疗之旅的每一步提供临床益处。”

Xermelo最常见的副作用是恶心、头痛、γ- 谷氨酰转移酶水平增加、抑郁症、液体积聚引起肿胀(外周性水肿)、肠胃气胀、食欲下降及发烧。Xermelo可引起便秘,在每天排便次数少于4次的患者中,发生便秘的风险可能会增加。

批准是基于两项随机三期临床试验TELESTAR和TELECAST的结果。临床试验中,使用高于推荐剂量Xermelo治疗的患者出现过严重便秘。一名患者需要住院治疗,另有两名患者出现胃肠穿孔或肠梗阻并发症。应对患者的便秘进行监测。如果患者经历严重便秘,或严重的、持续的或恶化的腹痛,应停止使用Xermelo,并与其医疗服务商联系。

ENETS卓越中心的DieterH?rsch医学博士对此表示:“作为参与过治疗类癌症患者的医生,我受到欧洲许可Xermelo?这一决定的鼓舞,批准为这一难以治疗的疾病提供了新治疗方案。在Xermelo?临床试验中,我们观察到患者生活质量发生了深刻改善。积极的安全和有效性数据促使其迅速融入临床实践指南。“

国际神经内分泌癌联盟(INCA)执行主任Teodora Kolarova 2称,“与类癌综合征相关的严重和不可预测的腹泻对患者的生活具有显着的负面影响。受这种情况影响的大多数患者的身体和心理健康都受到了严重影响。获得新的治疗方法,更多的信息和支持,对于这类人群来说是十分值得的。”

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    2018-01-01 soongzhihua
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    2017-09-23 chengjn
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    2017-09-23 xuqianhua
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