MYR制药公司对用于慢性D型肝炎感染的一流的进入抑制剂HEPCLUD

StephenW

MYR Pharmaceuticals receives positive CHMP opinion for HEPCLUDEX® (bulevirtide), the First-in-Class Entry Inhibitor for the treatment of chronic hepatitis D infections

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MYR Pharmaceuticals

May 29, 2020, 12:34 ET

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BAD HOMBURG, Germany, May 29, 2020 /PRNewswire/ -- MYR Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization (CMA) for the medicinal product HEPCLUDEX® (bulevirtide, formally known as Myrcludex B). HEPCLUDEX® is intended for the treatment of chronic hepatitis delta virus (HDV) infection in HDV-RNA positive adult patients with compensated liver disease. HEPCLUDEX® is a first-in-class entry inhibitor that binds and inactivates the essential hepatitis B (HBV) and HDV receptor on hepatocytes.
The benefit of HEPCLUDEX® is shown by an effective reduction of HDV RNA levels and improvement of liver inflammation.
"There is a high unmet medical need for patients suffering from chronic HDV infection," said Alexander Alexandrov, Chief Medical Officer of MYR GmbH. "We are encouraged by today´s positive CHMP opinion reinforcing the potential to become the first approved therapy for this most severe form of viral hepatitis."
The European Commission (EC) will review the CHMP recommendation and a final decision on the Conditional Marketing Authorization for HEPCLUDEX® in the EU is expected in the coming months. Upon positive EC decision, bulevirtide will be available under the trade name HEPCLUDEX® in the EU.
About HEPCLUDEX® (bulevirtide)
HEPCLUDEX® is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor (NTCP receptor) on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. HEPCLUDEX® has received Orphan Designation for treatment of HDV infection from EMA and FDA, PRIME scheme eligibility from EMA, and a breakthrough therapy designation from FDA.
About MYR Pharmaceuticals
MYR Pharmaceuticals is a German biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company`s lead compound HEPCLUDEX® is currently investigated in Phase 3 study in the indication chronic hepatitis delta.
Contact Details
Thomas Christély (CFO, MYR GmbH)
Phone: +49 (0) 6172 – 49 59 811
Email: [email protected]
SOURCE MYR Pharmaceuticals

StephenW

MYR制药公司对用于慢性D型肝炎感染的一流的进入抑制剂HEPCLUDEX®（bulevirtide）获得了CHMP的积极评价

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MYR制药

2020年5月29日，美国东部时间12:34

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2020年5月29日，德国巴德洪堡/ PRNewswire /-MYR Pharmaceuticals今天宣布，欧洲药品管理局（EMA）的人用药用产品委员会（CHMP）通过了积极的意见，建议准予有条件的营销药品HEPCLUDEX®（布列维肽，正式称为Myrcludex B）获得授权（CMA）。 HEPCLUDEX®用于治疗患有代偿性肝病的HDV-RNA阳性成人患者的慢性肝炎三角洲病毒（HDV）感染。 HEPCLUDEX®是一流的进入抑制剂，可结合并灭活肝细胞上的必需乙型肝炎（HBV）和HDV受体。

有效降低HDV RNA水平并改善肝脏炎症显示出HEPCLUDEX®的优势。

MYR GmbH首席医学官Alexander Alexandrov表示：“对于患有慢性HDV感染的患者存在高度未满足的医疗需求。 “我们对今天的CHMP积极看法感到鼓舞，这增强了其成为这种最严重形式的病毒性肝炎的首个获批疗法的潜力。”

欧盟委员会（EC）将审核CHMP建议，并有望在未来几个月内就欧盟对HEPCLUDEX®的有条件营销授权做出最终决定。根据EC的积极决定，在欧洲，将以商品名HEPCLUDEX®出售bulevirtide。

关于HEPCLUDEX®（布列维肽）
HEPCLUDEX®是用于治疗慢性乙型和丁型肝炎感染的一流进入抑制剂。该药物抑制肝细胞表面的HBV受体（NTCP受体），并防止健康细胞的感染和病毒在肝脏内的传播。 HEPCLUDEX®已获得EMA和FDA颁发的HDV感染孤儿治疗指定，EMA授予PRIME计划资格以及FDA突破性治疗指定。

关于MYR制药
MYR Pharmaceuticals是一家德国生物技术公司，专注于治疗慢性乙型和丁型肝炎病毒感染的药物。目前，该公司的主要化合物HEPCLUDEX®已在3期研究中针对慢性肝炎三角洲适应症进行了研究。

联系方式
ThomasChristély（MYR GmbH首席财务官）
电话：+49（0）6172 – 49 59 811
电子邮件：[email protected]

消息来源MYR Pharmaceuticals