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拜耳含钆磁共振造影剂Gadovist(加乐显)获日本批准

来源:生物谷 2015-03-27 14:04

2015年3月26日讯 /生物谷BIOON/ --德国制药巨头拜耳(Bayer)近日宣布,Gadovist(商品名:加乐显,通用名:gadobutrol,钆布醇)注射液获日本批准用于核磁共振成像(MRI)诊断,该药是日本批准的首个高浓度/高弛豫钆造影剂,适用于人体多个部位的对比增强磁共振成像(contrast-enhacement MRI,CE-MRI)诊断,包括脑、脊髓、血管、肝和肾,该药用药剂量为0.1毫升/公斤体重。据统计,在日本每年开展超过160万例对比增强核磁共振成像(CE-MRI)检查。

Gadovist的获批,是基于在日本开展的2项关键临床试验的数据。一项涉及223例患者的开放标签III期研究证明了gadobutrol增强MRI在中枢神经系统(CNS)相对于非增强MRI的优越性。另一项亚洲III期研究证明了gadobutrol增强MRI在身体其他部位(乳腺、心脏、肾脏、腹部、盆骨、下肢)相对于采用钆喷酸葡胺(gadopentetate dimeglumine)获得的增强MRI的非劣效性。

Gadovist是1.0摩尔浓度钆布醇水溶液的商品名,其他地区商品名为Gadovist 1.0,美国商品名为Gadavist。该药是一种基于钆(Gd)的细胞外造影剂,用于核磁共振成像(MRI)。Gadovist于1998年2月首次在瑞士获批,之后陆续在澳大利亚、加拿大、欧盟、美国及其他国家上市。目前,Gadovist已获全球100多个国家批准。

关于加乐显(Gadovist)

加乐显是一种新型的强效磁共振成像对比剂,被批准用于人体多个部位的对比增强磁共振成像(CE-MRI)诊断,包括脑、脊髓、血管、肝和肾。加乐显含1.0mol/L浓度的钆布醇,为市场上其他含钆对比剂浓度的两倍。此外,加乐显含有高浓度的离子态T1-弛豫效能。鉴于其高浓度和高弛豫效能,加乐显在所有含钆对比剂中显示了每毫升最高的短T1效能。这使得加乐显拥有优异的图像质量,并具备使用剂量更小的实用优点。(生物谷Bioon.com)

英文原文:Bayer receives approval for Gadovist? (gadobutrol) injection in Japan

First high concentration/high relaxivity gadolinium-based contrast agent approved in Japan / Indicated for contrast-enhancement MR imaging in cranial, spinal, the body and extremeties at a dose of 0.1 mL/kg body weight

Leverkusen, March 26, 2015 – Bayer HealthCare received approval in Japan for Gadovist? (gadobutrol) injection for use with magnetic resonance imaging (MRI). Gadovist is the first high concentration/high relaxivity gadolinium-based contrast agent to be approved in Japan and is indicated for contrast-enhancement MRI in cranial, spinal, the body and extremeties at a dose of 0.1 mL/kg body weight. In Japan, there are more than 1.6 million MRI procedures conducted annually which are contrast-enhanced.

“The approval of Gadovist in Japan provides local radiologists with access to the first high concentration/high relaxivity gadolinium-based contrast agent,” said Dr. Christiane Pering, Chief Medical Officer (CMO) and Head of Innovation within Bayer HealthCare’s Medical Care division. “Gadovist has demonstrated efficacy in providing the potential of high quality images of the central nervous system and whole body for patients supporting effective diagnosis and disease management by their healthcare teams and ultimately enabling good patient care.”

The approval of Gadovist in Japan was based on two key clinical studies involving patients from Japan. A 223-patient Phase 3 open label study in Japan demonstrated superiority of gadobutrol-enhanced MRI of the central nervous system (CNS) compared to unenhanced MRI. (1) A 363-patient Pan-Asian Phase 3 study with 120 Japanese patients demonstrated non-inferiority of gadobutrol-enhanced MR images of the body (breast, heart, abdomen, kidney, pelvis and extremity) to those obtained through the use of gadopentetate dimeglumine. (2) These studies and other supportive studies provided safety data on more than 550 Japanese patients dosed with Gadovist. Studies submitted to the health authority in Japan totaled 6599 patients, of which more than 1900 were Asian, and demonstrated that the safety profile of gadobutrol in the Asian population was consistent with global clinical studies. (3)

Gadovist is formulated at twice the concentration (1 M/L) of other gadolinium-based contrast agents (GBCAs), resulting in a lower volume per administration and a more compact contrast bolus. It also has greater relaxivity than other GBCAs. Relaxivity is a measure of the ability of MR-contrast agents, to shorten the relaxation times. A high-relaxivity contrast agent may improve signal intensity and contrast enhancement in MR images.

About the Gadovist Studies in Japan
There were two key studies upon which the approval of Gadovist by Japan’s MHLW is based:
? Phase 3 open-label study conducted in Japan investigated the efficacy and safety of Gadovist comparing “combined unenhanced and gadobutrol enhanced MRI” (“combined” hereafter) with “unenhanced MRI” in patients referred for contrast-enhanced MRI of central nervous system (CNS). The study enrolled 223 patients. Superiority of “combined MRI” to “unenhanced MRI” was proven for “degree of contrast enhancement,” “border delineation,” and “internal morphology” and non-inferiority was proven for number of lesion detected based on “average reader” results. (1)
? Phase 3 randomized pararell-group comparison study was conducted in Japan, Korea and China involving 363 patients, of which 120 subjects were Japanese. In this study the efficacy and safety of Gadovist was evaluated comparing “combined MRI with gadobutrol” with “combined MRI with gadopentetate dimeglumine” at dose of 0.1mmol/kg in patients referred for contrast-enhanced body MRI (breast, heart, abdomen, kidney, pelvis and extremity). Non-inferiority of contrast-enhanced MR images of gadobutrol 0.1mmol/kg and to those of Magnevist? (gadopentetate dimeglumine) 0.1mmol/kg in total scores of degree of contrast enhancement, border delineation and internal morphology was proven based on “average reader” results. (2)

About Gadovist
Gadovist, also known as Gadovist 1.0 in other regions and Gadavist? in the U.S., is the brand name of the aqueous 1.0M solution of gadobutrol, a gadolinium (Gd)-based extracellular contrast agent for MRI with a macrocyclic structure.

Gadovist was first approved in February 1998 in Switzerland, followed by approvals in Australia, Canada, the European Union (EU), and other countries. Today, Gadovist has been approved in more than 100 countries worldwide.

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