MYR Pharmaceuticals获得了欧洲委员会HEPCLUDEX®的有条件营销授

StephenW

MYR Pharmaceuticals receives Conditional Marketing Authorization by the European Commission for HEPCLUDEX®

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MYR Pharmaceuticals

Aug 04, 2020, 04:51 ET

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BAD HOMBURG, Germany, Aug. 4, 2020 /PRNewswire/ -- MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the European Commission (EC) has granted the Conditional Marketing Authorization (CMA) for their lead compound HEPCLUDEX®.

HEPCLUDEX® has been approved as the first treatment option for adult patients with chronic hepatitis delta virus infection and compensated liver disease in Europe.

The drug was originally developed by scientists at the University of Heidelberg (Germany) and INSERM (France). Prof. Stephan Urban, co-inventor of Hepcludex, DZIF-Professor for Translational Virology at the University of Heidelberg and lead scientist in the continuing research program between MYR Pharmaceuticals and Heidelberg University expresses his enthusiasm:" Today's approval marks a great achievement for patients suffering from the most severe form of viral hepatitis without any specific treatment option until today.  I am excited that after more than 20 years of scientific and clinical research, the entry inhibitor Myrcludex B, now HEPCLUDEX®, becomes accessible to patients and will significantly improve their lives."

The CMA is based on the results from two Phase II studies (MYR202 and MYR203), which demonstrated good tolerability and safety as well as significant reduction of viremia and improvement of liver function during treatment with HEPCLUDEX®.

Currently, MYR Pharmaceuticals has one Phase III HDV study ongoing evaluating the long-term treatment of HEPCLUDEX® and one Phase II HDV study investigating the combination of HEPCLUDEX® with pegylated interferon.

About HEPCLUDEX® (INN = bulevirtide)
HEPCLUDEX® represents the most clinically advanced novel approach for the treatment of hepatitis D, and is currently in a Phase 3 study in the indication of chronic HDV. The drug inhibits the HBV/HDV receptor NTCP on the hepatocyte surface and prevents the infection of regenerating cells and viral spreading within the liver. HEPCLUDEX® has received Orphan Drug Designation for treatment of HDV infection from the European Medicines Agency (EMA) and from the U.S. Food & Drug Administration (FDA). In addition, the EMA has granted PRIority MEdicines (PRIME) scheme eligibility. In parallel the FDA has granted Breakthrough Therapy designation - a process designed to expedite the development and review of drugs which may demonstrate substantial improvements on a clinically significant endpoint. The development of HEPCLUDEX® has been supported by a grant from the German Center for Infection Research (DZIF; www.dzif.de/en), a foundation which was initiated by the German Federal Ministry of Education and Research (BMBF).

About MYR Pharmaceuticals
MYR Pharmaceuticals is headquartered in Bad Homburg (Germany). The company started operations in 2011 and is supported by venture capital investors such as the High-Tech-Gründerfonds (www.htgf.de/en/) and Maxwell Biotech Venture Fund. More information is available at:

www.myr-pharma.com/

www.klinikum.uni-heidelberg.de/n ... -wird-therapierbar/

Contact Details
Thomas Christély, CFO
Phone: +49 (0)6172-4959811
Email: [email protected]

SOURCE MYR Pharmaceuticals

StephenW

MYR Pharmaceuticals获得了欧洲委员会关于HEPCLUDEX®的有条件营销授权

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MYR制药

2020年8月4日，美国东部时间04:51

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德国巴特洪堡，2020年8月4日/美通社/-MYR Pharmaceuticals是一家专注于慢性乙型和丁型肝炎治疗药物开发和商业化的德国生物技术公司，欣然宣布，欧盟委员会（EC）已为其铅化合物HEPCLUDEX®获得了有条件的市场销售授权（CMA）。

在欧洲，HEPCLUDEX®已被批准为患有慢性肝炎三角洲病毒感染和代偿性肝病的成年患者的首个治疗选择。

该药物最初是由海德堡大学（德国）和INSERM（法国）的科学家开发的。 Hepcludex的共同发明人，海德堡大学DZIF转化病毒学教授，MYR制药公司与海德堡大学之间持续研究计划的首席科学家Stephan Urban教授表达了他的热情：“今天的批准标志着患者痛苦的巨大成就从最严重的病毒性肝炎形式到今天没有任何特殊的治疗方法，令我兴奋的是，经过20多年的科学和临床研究，进入抑制剂Myrcludex B（现为HEPCLUDEX®）可供患者使用，并将显着改善他们的生活。”

CMA基于两项II期研究（MYR202和MYR203）的结果，这些研究显示出良好的耐受性和安全性，并在用HEPCLUDEX®治疗期间显着降低了病毒血症和改善了肝功能。

目前，MYR制药公司正在进行一项III期HDV研究，以评估HEPCLUDEX®的长期治疗，另一项II期HDV研究，研究HEPCLUDEX®与聚乙二醇化干扰素的组合。

关于HEPCLUDEX®（INN = bulevirtide）
HEPCLUDEX®代表了治疗D型肝炎的临床上最先进的新方法，目前正处于有关慢性HDV适应症的3期研究中。该药物抑制肝细胞表面的HBV / HDV受体NTCP，并防止再生细胞感染和病毒在肝脏内扩散。 HEPCLUDEX®已获得欧洲药品管理局（EMA）和美国食品药品管理局（FDA）颁发的用于治疗HDV感染的孤儿药称号。此外，EMA还授予了优先医学（PRIME）计划资格。同时，FDA授予了突破性疗法称号-一种旨在加快药物开发和审查的过程，该过程可能会证明在临床上具有重要意义的终点方面有实质性改善。 HEPCLUDEX®的开发得到了德国感染研究中心（DZIF; www.dzif.de/en）的资助，该基金会是由德国联邦教育与研究部（BMBF）发起的。

关于MYR制药
MYR Pharmaceuticals的总部位于德国巴特洪堡。该公司于2011年开始运营，并得到了诸如High-Tech-Gründerfonds（www.htgf.de/en/）和Maxwell Biotech Venture Fund等风险投资人的支持。有关更多信息，请访问：

www.myr-pharma.com/

www.klinikum.uni-heidelberg.de/n ... -wird-therapierbar/

联系方式
首席财务官ThomasChristély
电话：+49（0）6172-4959811
电子邮件：[email protected]

消息来源MYR Pharmaceuticals

StephenW

First Hepatitis D Treatment Approved in Europe

Hepcludex, formerly known as Myrcludex B, suppressed hepatitis B and hepatitis D virus replication in clinical trials.

August 17, 2020 • By Liz Highleyman

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The European Medicines Agency—the European Union’s counterpart to the U.S. Food and Drug Administration (FDA)—has approved the first drug for the treatment of hepatitis D, or hepatitis delta, which can accompany and worsen the complications of hepatitis B.

The new drug, Hepcludex (bulevirtide), suppressed hepatitis D virus (HDV) and hepatitis B virus (HBV) replication and was well tolerated in Phase II clinical trials. It was granted conditional marketing authorization, equivalent to the FDA’s accelerated approval, and larger studies are underway.
歐洲首批批准的D型肝炎治療

Hepcludex（以前稱為Myrcludex B）在臨床試驗中抑制了B型肝炎和D型肝炎病毒的複制。

2020年8月17日•Liz Highleyman

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歐盟藥品監督管理局（FDA）的歐盟對口機構-歐洲藥品管理局（European Medicines Agency）已批准了首種用於治療D型肝炎或δ型肝炎的藥物，該藥物可伴隨並加重B型肝炎的並發症。

新藥Hepcludex（bulevirtide）可抑制D型肝炎病毒（HDV）和B型肝炎病毒（HBV）的複制，並且在II期臨床試驗中耐受性良好。 它獲得了有條件的市場銷售授權，相當於FDA的加速批准，並且正在進行較大的研究。

https://www.hepmag.com/article/f ... ent-approved-europe