强生丙肝新药simeprevir获FDA审查员积极意见

FDA审查员10月22日称，强生（JNJ）开发的一种新的丙型肝炎药物simeprevir在临床试验中表现出了可接受的安全性。

在相关临床试验中，调查了simeprevir与标准丙型肝炎药物聚乙二醇干扰素α和利巴韦林联合用药，用于既往未接受干扰素为基础的疗法或未经治疗的丙型肝炎成人患者的治疗。

在审查simeprevir的过程中，发现的主要安全信号为皮疹和/或光敏性，FDA审查员称，计划在该药的药物标签中纳入相关警告信息。

FDA审查员称，simeprevir在标签上将被归类为“妊娠C类”，这意味着该药的潜在益处可以保证其在孕妇中的使用，尽管动物试验表明，该药对胎儿有一些不良影响。

本周四，FDA的独立顾问委员会将讨论simeprevir的安全性和疗效，同时投票表决是否建议批准simeprevir，抑或警告信息的必要性，或是否需要开展进一步的研究。

丙型肝炎（HCV）是一种血源性传染性肝脏疾病，若不及时治疗，可能对肝脏造成重大损害。在美国，每年约有1.5万人死于该病，大多死于丙型肝炎相关疾病，如肝硬化和肝癌。

目前，投资者关注的是能排除使用注射药物干扰素的新型丙型肝炎药物。而需要与干扰素联合用药的丙型肝炎药物（如simeprevir），销售一直下滑，因为患者们正在等待具有高疗效且无干扰素副作用的新型全口服方案。

吉利德（Gilead）、Vertex制药、AbbVie、百时美施贵宝（BMS）等制药巨头均试图推出首个全口服治疗方案。

simeprevir是新一代NS3/4A蛋白酶抑制剂，由Medivir公司和杨森（Janssen）联合开发，用于治疗慢性丙型肝炎成年患者的代偿性肝病，包括各个阶段的肝纤维化，其工作原理是通过阻断蛋白酶，来抑制HCV在肝脏细胞中的复制。

今年9月，simeprevir（商品名Sovriad）获日本劳动卫生福利部（MHLW）批准，与聚乙二醇化干扰素和利巴韦林（ribavirin）联合用药，用于基因型-1慢性丙型肝炎病毒（HCV）感染者的治疗，这是simeprevir获得的全球首个监管批准。

Sovriad为每日一次的口服胶囊，是一种新的直接作用抗病毒药物，也是第二代蛋白酶抑制剂，给药方式为：sovriad+聚乙二醇干扰素+利巴韦林联合治疗12周，随后进行聚乙二醇干扰素+利巴韦林治疗12周或36周。

英文原文：J&J's new hepatitis C drug gets positive FDA review

Tue Oct 22, 2013 11:42am EDT

Oct 22 (Reuters) - A new hepatitis C drug made by Johnson & Johnson showed an acceptable safety profile in clinical trials, reviewers for the U.S. Food and Drug Administration said on Tuesday.

The drug, simeprevir, was tested in combination with standard hepatitis C drugs, peginterferon-alpha and ribavirin, in adult patients who had failed previous interferon-based therapy or had not received medication at all.

J&J shares were up nearly 1 percent to $92 in morning trade on the New York Stock Exchange.

The major safety signal identified in the review of the drug involved rash and/or photosensitivity and the FDA reviewers said they plan to include a related warning in the drug's label. ()

The reviewers said that the drug would be categorized as a "Pregnancy Category C" in labeling, which means that the potential benefits of the drug may warrant its use in pregnant women, even though animal trials showed the drug had some adverse effects on a fetus.

The briefing documents were released prior to Thursday's meeting of an advisory panel of independent experts to discuss the drug's safety and efficacy, vote on an approval recommendation, and the need for warnings or further trials.

Hepatitis C, an infection of the liver transmitted through the blood, kills more than 15,000 Americans each year, mostly from hepatitis C-related illnesses, such as cirrhosis and liver cancer.

Investors are currently focused on new hepatitis C treatments that can exclude the use of the difficult-to-tolerate injected drug interferon.

Sales of hepatitis C drugs that are needed to be taken with interferon, like simeprevir, have been declining as patients wait for the all oral treatment regimens that promise high efficacy without the side effects of interferon.

Gilead Sciences Inc, Vertex Pharmaceuticals Inc , AbbVie and Bristol-Myers Squibb are all trying to come up with the first all-oral hepatitis C treatments.