Guerbet Announces U.S. Food and Drug Administration (FDA) Approval of Elucirem™ (Gadopiclenol)
Guerbet Announces U.S. Food and Drug Administration (FDA) Approval of Elucirem™ (Gadopiclenol)
Guerbet announces U.S. Food and Drug Administration (FDA) approval of Elucirem™ (Gadopiclenol)
格爾貝特宣佈美國食品和藥物管理局批准Elucirem™(加多匹克諾)
- FDA approval of EluciremTM (NDA 216986) was granted after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies.
- In the approved indications, a contrast-enhanced MRI examination using Elucirem™ requires half the gadolinium dose of existing non-specific GBCAs (gadolinium-based contrast agents), addressing practitioners' concerns about gadolinium exposure.1,2,3
- EluciremTM (Gadopiclenol) will be produced in the United States and France.
- EluciremTM will be marketed by Guerbet in the United States in bottle and pre-filled syringe form.
- FDA批准EluciremTM(NDA 216986)是經過優先審查後授予的，這是一項指定，分配給與現有治療方法相比，在治療、診斷或預防嚴重疾病的安全性或有效性方面提供重大改進的藥物申請。
- 在批准的適應症中，使用Elucirem™進行的對比度增強核磁共振檢查需要現有非特異性GBCA(基於Gd的造影劑)的一半Gd劑量，從而解決了從業者對Gd暴露的擔憂。1,2,3
- 埃盧西雷姆TM(Gadadiclenol)將在美國和法國生產。
- 埃盧西雷姆TM將由Guerbet以瓶裝和預裝注射器的形式在美國銷售。
Villepinte, France, September 21st 2022 – Guerbet (FR0000032526 GBT), a global leader in medical imaging, announced today that the U.S. Food and Drug Administration (FDA) after priority review, approved Elucirem™ (Gadopiclenol), a new macrocyclic GBCA for use in contrast-enhanced magnetic resonance imaging (MRI).
法國維爾品特，9月21日ST2022 – 全球醫學成像領先企業格爾貝特(GERBET)(FR0000032526GBT)今天宣佈，美國食品和藥物管理局(FDA)在經過優先審查後，批准了一種用於增強磁共振成像的新型大環™--Elucirem Gadoiclenol。
Elucirem™ (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent with high relaxivity indicated for use in adults and children aged 2 years and older, for contrast-enhanced magnetic resonance imaging (MRI). The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). Please refer to the FDA approved Prescribing Information on Drugs@FDA.4
Elucirem™(Gadadiclenol)是一種新型的高弛豫度大環Gd造影劑，適用於2歲及以上的成人和兒童，用於增強磁共振成像。該產品用於檢測和可視化中樞神經系統(大腦、脊柱和相關組織)和身體(頭部和頸部、胸部、腹部、骨盆和肌肉骨骼系統)中血管異常的病變。請參考FDA批准的藥品描述信息@FDA。4
Gadopiclenol, the active substance of EluciremTM, has been designed with two sites for water molecule exchange to increase relaxivity and contrast, allowing to use it at half the conventional dose of gadolinium compared to other non-specific GBCAs.
艾魯克瑞姆的活性物質GadadiclenolTM，設計了水分子交換的兩個部位，以增加弛豫度和對比度，使其與其他非特異性GBCA相比，能夠以傳統劑量的一半使用。
The efficacy and safety of Gadopiclenol have been assessed as part of Guerbet's clinical development plan, with marketing authorization being targeted worldwide (cf. phase III trial results below).
The FDA is the first health authority to have approved EluciremTM. It is currently in the process of examination by the European Medicines Agency via a centralized procedure.
Gadadiclenol的有效性和安全性已作為Guerbet臨牀開發計劃的一部分進行了評估，並在全球範圍內進行了上市授權(參見。第三階段試驗結果如下)。
FDA是第一個批准埃盧西雷姆TM。它目前正在由歐洲藥品管理局通過集中程序進行檢查。
"As a pioneer in MR imaging, thanks to the success of our first gadolinium-based macrocyclic contrast agent, we are delighted with the FDA approval of Elucirem™. This approval allows patients and practitioners to benefit from the innovations brought by Elucirem™"
作為磁共振成像領域的先驅，得益於我們第一種基於Gd的大環造影劑的成功，我們很高興食品和藥物管理局批准了Elucirem™。這一批准使患者和從業者能夠從Elucirem™帶來的創新中受益。
David Hale, Chief Executive Officer of Guerbet Group
格爾貝集團首席執行官David·黑爾
Phase III clinical trials for Elucirem™
Elucirem™的第三階段臨牀試驗
The approval was primarily based on data from two Phase III studies completed in March 2021 which demonstrated that Elucirem™ leads to non-inferior results in brain and body MRI at half the gadolinium dose of Gadobutrol.5,6 The endpoints were met in terms of the diagnostic benefit of injecting Gadopiclenol (0.05 mmol/kg) during MRI examinations, based on two criteria:
1/ the superiority of the examination with Gadopiclenol compared to the examination with no contrast agent;
and 2/ the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied.
批准主要是基於2021年3月完成的兩項第三階段研究的數據，這兩項研究表明，Elucirem™在腦部和身體核磁共振中的結果並不遜色，劑量是Gadobutrol的一半。5,6根據兩個標準，在MRI檢查期間注射Gadadiclenol(0.05 mmol/kg)的診斷益處符合終點標準：
1/與不加造影劑的檢查相比，使用加多比索的檢查具有更大的優越性；
在中樞神經系統和研究的其他解剖區域的可視化和檢測方面，Gadadiclenol(0.05 mm o l/kg)與Gadobutrol(0.1 m o l/kg)相比並不遜色。
No major safety signals were reported during the development of Gadopiclenol, and the adverse reactions reported during the two-Phase III studies were similar for both products administered. Please refer to the FDA approved Prescribing Information on Drugs@FDA.7
在Gadadiclenol的開發過程中沒有報告重大的安全信號，在兩個第三階段研究期間報告的兩種產品的不良反應相似。請參考FDA批准的藥品描述信息@FDA。7
Details on these two clinical trials are available in the database:
有關這兩項臨牀試驗的詳細信息可在數據庫中找到：
- Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov
- Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov
- Gadadiclenol治療中樞神經系統(CNS)磁共振成像(MRI)的有效性和安全性-全文-ClinicalTrials.gov
- Gadadiclenol用於人體磁共振成像(MRI)的有效性和安全性-全文查看-ClinicalTrials.gov
Production of Elucirem™ (Gadopiclenol)
艾魯克瑞姆™(加多匹克諾)的生產
The production of Gadopiclenol will take place at one Guerbet's US and at three French plants. Those three French plants employ approximately 700 people in production and research & development.
Gadadiclenol的生產將在格爾貝特的一家美國工廠和三家法國工廠進行。這三家法國工廠在生產和研發方面僱傭了大約700名員工。
About Gadopiclenol
Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of Gadopiclenol have been evaluated in MRI of the Central Nervous System, head and neck, thorax, abdomen, pelvis and musculoskeletal system (refer to the approved USPI for full information). Details on Phase III clinical trials are available on :
關於加多比克洛爾
Gadadiclenol是一種新型的高弛豫度大環格拉基造影劑(GBCA)，最初由Guerbet發明，後來得到Bracco知識產權的貢獻。Gadadiclenol的有效性和安全性已經在中樞神經系統、頭頸、胸部、腹部、骨盆和肌肉骨骼系統的MRI中進行了評估(有關詳細信息，請參閲批准的USPI)。有關第三階段臨牀試驗的詳細信息，請訪問:
- Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov
- Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) - Full Text View - ClinicalTrials.gov
- 加多匹克洛爾用於中樞神經系統磁共振成像的有效性和安全性全文視圖-ClinicalTrials.gov
- 加多匹克洛爾用於人體核磁共振成像的有效性和安全性全文視圖-ClinicalTrials.gov
Gadopiclenol is currently in the process of examination by the European Medicines Agency.
Gadadiclenol目前正在接受歐洲藥品管理局的檢查。
About Guerbet
At Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a global leader in medical imaging, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. As pioneers in contrast products for 95 years, with more than 2,600 employees worldwide, we continuously innovate and devote 8%-10% of our revenue to research and development in five centers in France, Israel, and the United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €732 million in revenue in 2021. For more information, please visit .
關於格爾貝
在格爾貝，我們建立持久的關係，讓人們生活得更好。這就是我們的目標。我們是醫療成像領域的全球領先者，提供全方位的藥品、醫療設備以及用於診斷和介入成像的數字和人工智能解決方案。作為擁有95年曆史的對比產品的先驅，我們在全球擁有2600多名員工，我們不斷創新，並將8%-10%的收入投入法國、以色列和美國的五個中心的研發。格爾貝在巴黎泛歐交易所上市(B段 - 中型股)，2021年創造了7.32億歐元的收入。欲瞭解更多信息，請訪問.
About Guerbet and Bracco Imaging Collaboration
Guerbet and Bracco Imaging entered in December 2021 into a worldwide collaboration on Gadopiclenol manufacturing and research and development indicate. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco Imaging, both companies will manufacture Gadopiclenol active ingredient and finished product.
關於Guerbet和BrTobo圖像合作
格爾貝特和布拉科成像公司於2021年12月在加多比克洛爾的製造和研發方面進行了全球合作。Gadadiclenol將在不同的品牌下獨立商業化。格爾貝和布拉科成像公司都擁有加多比克洛爾的寶貴知識產權。此外，經過一段商定的過渡期後，格爾貝公司將為格爾貝公司和布萊克成像公司生產Gadadiclenol，這兩家公司將生產Gadadiclenol的活性成分和成品。
Forward-looking statements
This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website .The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.
前瞻性陳述
本新聞稿可能包含基於Guerbet集團管理層的假設和預測的前瞻性陳述。各種已知和未知的風險、不確定性和其他因素可能會導致公司未來的業績、財務狀況、發展和業績與此處做出的估計存在顯著差異。這些因素包括格爾貝的公開報告中提到的那些因素，可在其網站上查閲.對於這些前瞻性陳述的更新，或它們如何與未來的事件或發展相對應，該公司不承擔任何責任。
[1] PRAC, European Medicines Agency, 2017
[1]歐洲藥品管理局，2017年
2 FDA Drug Safety Communication, 2017
2FDA藥品安全溝通，2017年
3 Brunjes et al. Water Research, 2020
3Brunjes等人。水研究，2020年
4
4
5
5
6
6
7
7
Contacts:
聯繫人:
Guerbet
Claire Lauvernier, Group Communication Director +33.6.79.52.11.88 / claire.lauvernier@guerbet.com
格爾貝
電話：+33.6.79.52.11.88電子郵件：claire.lavernier@guerbet.com
Actifin
Mathias Jordan, Media Relations +33.1.56.88.11.26 / mjordan@actifin.fr
激活
媒體關係部馬蒂亞斯·喬丹電話：+33.1.56.88.11.26電子郵件：mjordan@actifin.fr
Attachment
依附
- CL FV Guerbet_PR Elucirem AMM FDA UK V9
- CL FV Guerbet_PR Elucirem AMM FDA UK V9
譯文內容由第三人軟體翻譯。