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首页 » FDA信息 » 拜耳造影剂Gadavist新适应症获FDA批准,用于两周岁以下患儿

拜耳造影剂Gadavist新适应症获FDA批准,用于两周岁以下患儿

来源:生物谷 2015-01-06 16:36

2015年1月6日讯/生物谷BIOON/--近日,拜耳制药宣布FDA批准了该公司Gadobutrol(钆布醇,美国商品名为Gadavist注射剂)用于两周岁以下患儿(包括新生儿),与成人标准注射剂量相同。

Gadobutrol最初被批准用于血脑屏障破坏和(或)中枢神经系统血管异常的患者进行MRI检查,用于发现和定位受损区域。该注射剂可以产生加强影像,帮助医生更加精确地分析异常情况。

拜耳制药的首席医疗负责人Christiane Pering表示,Gadavist是第一个被FDA批准的用于两周岁以下患儿、并且以钆为主要成分的造影剂。

此前的研究表明,Gadavist对于两周岁以下患儿的药物代谢动力学(研究药物在人体的运动和分布)和安全性与两周岁以上患者相似,因此该药物获得了FDA的优先审批权。此项研究过程中,共47名患儿在美国、欧洲、加拿大等地区共9个实验中心进行试验。该药的安全性已经在总共6330名患者的临床试验中得以验证。

加拿大阿尔伯塔大学的儿科放射学家Ravi Bhargava表示,医生对于造影检查准确性的要求越来越高,因此对于安全高效的造影剂具有很大的需求,而Gadavist获批对于那些需要获取中枢神经系统异常区域准确影像的患儿的治疗评估也有很大益处。

注射Gadavist后,可以获取加强MRI影像,比未注射造影剂的患者效果好得多。

2011年3月,Gadavist首次获批用于2周岁以上患者的MRI造影,用来定位血管异常;2014年6月,Gadavist被批准用于乳房MRI造影,用来定位恶性乳腺疾病,比如乳腺癌。

目前,Gadovist的补充适应症在欧洲的评审仍在继续。(生物谷Bioon.com)

原文 FDA Approves Bayer’s (BAYRY) Gadavist

Bayer AG (ADR) (OTCMKTS:BAYRY) announced today that the FDA has granted a label expansion approval for the additional use of its drug, Gadobutrol (marketed in the US as Gadavist injections), for pediatric patients younger than 2 years of age (including term neonates), at the standard injection dose given to adults.

The injection was granted approval to be used with an MRI to find and sketch out the regions in a patient’s body with a disrupted blood-brain barrier and/or abnormal central nervous system blood vessels. The injection helps produce enhanced images, allowing the abnormalities to me analyzed more accurately.

“Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under 2 years of age,” as mentioned by Christiane Pering, chief medical officer and head of innovation within Bayer HealthCare’s Medical Care division.

The drug received an FDA priority review after a study demonstrated that the pharmacokinetic (the movement and distribution of the drug in a body) and the safety profiles of the drug in patients younger than 2 years of age were similar to those in patients older than 2 years. 47 pediatric patients were enrolled in the study in 9 centers in the US, Europe, and Canada. The safety of the drug has been demonstrated in several clinical trials on 6,330 patients in total.

Dr. Ravi Bhargava, pediatric radiologist at the University of Alberta, said there is a great need for effective and safe treatments, as doctors need to detect the areas of abnormalities in pediatric patients’ bodies more accurately. Also, accurate images for the abnormal regions of the central nervous system in young patients need to be assessed by the treatments.

The MRIs enhanced by injecting patients with Gadavist have produced better images than the unenhanced MRIs.

Gadavist was originally approved in the US by the FDA for the same treatment in patients older than 2 years of age in March 2011, to help produce enhanced MRIs to locate vascular abnormalities. Furthermore, the injectable drug was approved in June 2014 for the MRI of breasts to locate malignant breast diseases, including breast cancer. About 40,000 women died of breast cancer in the US in June 2013.

A supplemental application for Gadovist – the name used for Gadavist outside US – is currently under review by the regulatory authorities in the EU.

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