返回搜索结果

资讯详情

<< 上一篇 下一篇 >>

杨森向FDA提交地瑞那韦/Cobicistat复方药物上市申请

发布时间:2014年04月06日 17:13:21

强生下属子公司杨森正在寻求FDA批准由旗下HIV治疗药物地瑞那韦与吉利德Cobicistat组成的复方药物。这款复方药物的批准将减轻HIV患者的用药负担,不再需要患者服用地瑞那韦的同时服用一款单独的增强剂。

 

这款复方药物或会帮助提高治疗药物的依从性,对那些HIV感染患者来说要获得理想的预后,依从性是非常关键的。根据强生提供的信息,目前全球有3450万HIV感染患者,每年新增病例250万。但经过8个月的治疗后,只有65%的患者有100%的依从性。如果能够获得FDA批准,这款固定剂量的复方药物将以一种新的品牌名上市销售。

 

Janssen files Prezista/booster combo with FDA

Johnson & Johnson group Janssen is seeking approval in the US to market a combination of its hugely popular HIV therapy Prezista (darunavir) and Gilead's cobicistat in a single pill.

 

Approval of the combo would reduce the pill burden for HIV patients, for the first time eliminating the need for patients to take a separate booster pill alongside the darunavir therapy.

 

 This could potentially help improve treatment adherence, which is crucial to achieving the best possible outcomes for those infected with the virus.

 

 According to J&J, there are 34.5 million people living with HIV globally with 2.5 million newly infected each year. But, after just eight months of treatment, only 65% achieve 100% compliance, highlighting the scope for improvement.

 

 If a green light is received from the US Food and Drug Administration, the fixed-dose combination pill will be marketed under a new brand name by Janssen, the firm said. 

 

 

<< 上一篇 下一篇 >>