向Bulevirtide授予Hep D有前途的创新药物

StephenW

Promising Innovative Medicine granted to Bulevirtide for Hep D
6th March 2019


Anna Smith

MYR Pharma has bagged Promising Innovative Medicine (PIM) status in the UK for Bulevirtide (myrcludex), its first-in-class entry inhibitor for the treatment of chronic hepatitis delta (HDV) infections.

The decision indicates that that the Medicines and Healthcare products Regulatory Agency (MHRA) believes the drug is a strong contender for the UK's Early Access to Medicines Scheme (EAMS), which gives patients with life threatening or seriously debilitating conditions access to medicines before they are approved for use in Europe.

In the second stage of the process, the Agency issues an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value, paving the way for patient access, opening up access before a regulatory decision is reached.

"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."

The first-in-class entry inhibitor has already received Orphan Designation for the treatment of HDV infection from the European Medicines Agency (EMA) and the Food and Drug Administration (FDA), PRIority Medicines scheme (PRIME) scheme eligibility from the EMA, and a breakthrough therapy designation from the FDA.

HDV is a virus that requires hepatitis B virus (HBV) for its replication. HDV infection occurs only simultaneously or as super-infection with HBV, and at least 5% of people with chronic HBV infection are co-infected with HDV, resulting in a total of 15 - 20 million persons infected with HDV worldwide.

StephenW

向Bulevirtide授予Hep D有前途的创新药物
2019年3月6日


安娜史密斯

MYR Pharma在英国为Bulevirtide（myrcludex）提供了有希望的创新医学（PIM）地位，Bulevirtide是其用于治疗慢性乙型肝炎（HDV）感染的一流入门抑制剂。

该决定表明，药品和医疗保健产品监管机构（MHRA）认为该药物是英国早期药品计划（EAMS）的有力竞争者，该计划为患者提供危及生命或严重衰弱的条件。批准在欧洲使用。

在该过程的第二阶段，如果为支持该应用而提供的质量，安全性和有效性数据足以支持积极的利益/风险平衡并增加临床价值，则该机构发布EAMS科学意见，为患者获取铺平了道路，在达成监管决定之前开放访问权限。

“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。”

一流的进入抑制剂已经从欧洲药品管理局（EMA）和食品和药品管理局（FDA），EMA的PRIority Medicines scheme（PRIME）计划资格中获得了用于治疗HDV感染的Orphan Designation，以及来自FDA的突破性治疗指定。

HDV是一种需要乙型肝炎病毒（HBV）复制的病毒。 HDV感染仅同时或作为HBV的超感染发生，并且至少5％的慢性HBV感染者与HDV共感染，导致全世界共有1500万至2000万人感染HDV。