FDA considers Merck's boceprevir

StephenW

By JENNIFER CORBETT DOOREN            A Food and Drug Administration staff review of Merck & Co.'s proposed hepatitis C drug boceprevir has raised safety concerns about anemia and other blood disorders.
But the review also said it agreed with Merck's analysis showing adding boceprevir to other drugs currently used to treat hepatitis C was significantly more effective at treating the condition. Broadly, two studies submitted to the FDA in support of boceprevir showed more patients responded to treatment by achieving a so-called sustained virologic response. However, certain groups such as African-Americans and patients with more advanced hepatitis C didn't respond as well.
Boceprevir faces a review by the FDA's Antiviral Drugs Advisory Committee on Wednesday. A similar product, telaprevir, from Vertex Pharmaceuticals Inc., will be reviewed by the panel on Thursday. Both drugs are widely expected to be recommended for approval, as they have shown strong effectiveness in improving the cure rates in patients that use standard therapy for the liver disease. Both drugs are known as protease inhibitors, which are designed to block an enzyme that helps the hepatitis C virus replicate.
Hepatitis C is a liver disease caused by infection with the hepatitis C virus, which is spread when the blood of an infected person enters the body of someone previously not infected. The Centers for Disease Control and Prevention said most people become infected by sharing needles or other equipment used to inject drugs, although the agency said people who receive body piercings or tattoos with nonsterile instruments are also at risk of becoming infected with hepatitis C. About 3.2 million Americans are infected with hepatitis C.
The FDA posted a review of boceprevir on its website on Monday. The main safety issue the agency raised with regard to boceprevir was an "increased frequency and severity of anemia" or a decrease in the number of red blood cells when boceprevir is added to pegylated interferon and ribavirin, two other drugs currently used to treat hepatitis C.
The agency also said there was an increased number of reported psychiatric symptoms of "suicidal and homicidal ideation" in the boceprevir arms of the studies compared to the control groups. However, the FDA said "it is difficult to make any meaningful clinical conclusions from this observation." Reports of suicidal ideation occurred in fewer than 1% of patients in the studies.
The FDA advisory panel is being asked to vote on whether it thinks the available data support the approval of boceprevir. The vote will amount to a recommendation about whether the panel thinks the agency should approve the product. The FDA is not required to follow the advice of its advisory panels but usually does.
The panel will also be asked to discuss whether certain patients, such as African-Americans, should receive longer therapy with boceprevir.
Merck, in a document also posted on FDA's website, said boceprevir "fulfils a significant unmet medical need" for the treatment of hepatitis C infection. Merck has proposed a brand name of Victrelis for boceprevir.
                Write to                 Jennifer Corbett Dooren at [email protected]            

StephenW

美国食品与药物管理局对默克公司的建议C型肝炎药物boceprevir工作人员审查，引发了人们贫血等血液病的安全问题。

不过，审查还表示，与默克的分析一致显示，加入boceprevir目前用来治疗丙型肝炎的治疗有显着更有效的其他药物的条件。从广义上讲，在提交给FDA boceprevir支持两项研究显示，更多的患者的反应是实现了所谓的持续病毒学应答治疗。然而，如非裔美国人和更先进的C型肝炎以及没有反应的病人某些群体。

Boceprevir面临着一个通过美国FDA的抗病毒药物顾问委员会周三审查。类似的产品，从顶点telaprevir制药公司，将会在周四审查小组。这两种药物被广泛预计将批准建议，因为他们已经表明在改善患者用于治疗肝脏疾病的治愈率标准的强烈效果。这两种药物被称为蛋白酶抑制剂，其目的是为了阻止一种酶，有助于丙型肝炎病毒复制。

丙型肝炎是一种肝脏疾病，与丙型肝炎病毒，是传播，当被感染者的血液进入了以前没有感染的人体内造成感染。美国疾病控制和预防中心说，大多数人感染通过共用针头或其他设备用于注射药物，虽然该机构说，人们谁接受身体穿孔或未经消毒的仪器纹身是在成为C型肝炎感染与风险也约3.2万美国人感染了丙型肝炎

美国食品药物管理局发布了boceprevir周一在其网站上检讨。主要的安全问题方面的机构提高到boceprevir是“增加的频率和严重程度的贫血”或在红血的时候boceprevir添加到聚乙二醇干扰素和利巴韦林，目前用于治疗丙型肝炎的其他两个药物的细胞数量减少。

该机构还表示，一对“自杀和杀人意念”在对照组相比，该研究报告的精神症状boceprevir武器数量增加。不过，FDA说：“这是困难的，从这个临床观察任何有意义的结论。”自杀意念报告发生在不到1％的患者进行的研究。

FDA的顾问小组被要求投票表决是否认为现有的数据支持boceprevir批准。投票将等同于该小组的建议是否应批准该机构认为该产品。 FDA目前并不需要遵循其顾问小组的建议，但通常不会。

该小组也将讨论是否要求某些患者，如非裔美国人，不再与boceprevir应接受治疗。

默克在文件中还张贴在FDA的网站，说boceprevir“满足一个重要的未满足的医疗需求”为丙型肝炎感染的治疗。默克公司提出了为boceprevir Victrelis品牌。

写在jennifer.corbett - dooren詹尼弗科尔韦特Dooren @ dowjones.com