MYR Pharma宣布授予美国FDA针对Myrcludex的突破性治疗指定

StephenW

MYR Pharma Announces Grant of Breakthrough Therapy Designation by US FDA for Myrcludex, the First-in-Class Entry Inhibitor for Treatment of chronic Hepatitis B and D Infections
PRESS RELEASE PR Newswire
Oct. 23, 2018, 11:46 AM

BURGWEDEL, Germany, Oct. 23, 2018 /PRNewswire/ -- MYR Pharma today announced that US Food and Drug Administration (FDA) has granted the Breakthrough Therapy designation for its lead compound Myrcludex. The designation is granted in the indication chronic hepatitis delta (HDV) infection. The designation allows to expedite the development and review of drugs intended for the treatment of serious or life-threatening diseases. HDV infection leads to the most severe viral hepatitis, and there is no FDA-approved drug for treatment of this condition.

"Myrcludex was very well tolerated and has shown compelling antiviral activity in clinical trials performed so far," said Alexander Alexandrov, MYR's Chief Medical Officer. "We are looking forward to working with the agency to accelerate the development program."

About Myrcludex
Myrcludex is a first-in-class entry inhibitor for treatment of chronic hepatitis B and D infections. The drug inhibits the HBV receptor on the hepatocyte surface and prevents the infection of healthy cells and viral spread within the liver. Myrcludex 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 Pharma
MYR Pharma is a German clinical stage biotechnology company focused on drugs for the treatment of chronic hepatitis B and D virus infections. The company's lead compound is currently progressing into Phase 3 studies in the indication chronic HDV infection.

Alexey Eliseev, 1-617-953-0767

StephenW

MYR Pharma宣布授予美国FDA针对Myrcludex的突破性治疗指定，Myrcludex是治疗慢性乙型肝炎和D型感染的一流入门抑制剂
新闻稿PR Newswire
2018年10月23日，上午11:46

德国BURGWEDEL，2018年10月23日/美通社/ - MYR Pharma今天宣布美国食品和药物管理局（FDA）已授予其先导化合物Myrcludex的突破性治疗称号。该指定在指示慢性肝炎三角洲（HDV）感染中被授予。该名称允许加快开发和审查用于治疗严重或危及生命的疾病的药物。 HDV感染导致最严重的病毒性肝炎，并且没有FDA批准的药物用于治疗这种病症。

“到目前为止，Myrcludex的耐受性非常好，并且在临床试验中显示出令人信服的抗病毒活性，”MYR的首席医疗官Alexander Alexandrov说。 “我们期待与该机构合作，加快发展计划。”

关于Myrcludex
Myrcludex是治疗慢性乙型和乙型肝炎感染的一流入门抑制剂。该药物抑制肝细胞表面的HBV受体，并防止健康细胞的感染和肝脏内的病毒传播。 Myrcludex已获得Orphan Designation治疗来自EMA和FDA的HDV感染，PRIME计划资格来自EMA，以及来自FDA的突破性治疗指定。

关于MYR Pharma
MYR Pharma是一家德国临床阶段生物技术公司，专注于治疗慢性乙型和乙型肝炎病毒感染的药物。该公司的主要化合物目前正在进展为慢性HDV感染的第3阶段研究。

Alexey Eliseev，1-617-953-0767

齐欢畅

的突破性治疗称号。该指定在指示慢性肝炎三角洲（HDV）感染中被授予。该名称允许加快开发和审查用于治疗严重或危及生命的疾病的药物。 HDV感染导致最严重的病毒性肝炎，并且没有FDA批准的药物用于治疗这种病症。

灵魂不屈

好消息，感谢分享。