百时美施贵宝(Bristol-Myers Squibb ，BMS)近日宣布已经向FDA提交申请，要求批准应用蛋白酶抑制剂Reyataz(Atazanavir，阿扎那韦)和cobicistat（该药是由吉利德科技公司开发的一种药物动力学增强剂，是抗艾滋病药物增强剂，可提高特定HIV-1药物的血药浓度，使药物更加有效）的固定剂量复方制剂，该产品可结合其他疗法用于治疗HIV - 1感染。
制药公司表示, Reyataz/cobicistat固定剂量组合制剂的疗效和安全性已被三期临床试验证明，与单独使用Reyataz治疗HIV-1感染者相当。Reyataz在2003年被FDA批准用于和其他抗逆转录病毒药物联合治疗HIV - 1感染，主要用于首次应用和曾经使用过抗逆转录病毒药物治疗的成年以及6岁以上的儿科患者。
2011年,百时美施贵宝授权进行一日剂量的Reyataz/cobicistat组合片剂的开发和市场化。根据协议条款,百时美施贵宝负责Reyataz/cobicistat组合片剂在全球范围内的开发、生产及商业化。与此同时, 吉利德保留保留生产、开发和商业化cobicistat作为一种独立产品及与其他药剂组合用药的独家权利。本月早些时候,强生公司研发单位申请FDA批准蛋白酶抑制剂Prezista(Darunavir，地瑞那韦)和cobicistat的一日固定剂量组合片剂。
Bristol-Myers Squibb seeks FDA approval for combination of Reyataz, Gilead Sciences' cobicistat
Bristol-Myers Squibb announced Monday that it has submitted a filing seeking FDA approval of a fixed-dose combination of the protease inhibitor Reyataz (atazanavir) and Gilead Sciences' pharmacokinetic enhancer cobicistat for the treatment of HIV-1 infection in combination with other therapies.
The drugmaker said that the application is supported by a Phase III study comparing the efficacy and safety of cobicistat-boosted Reyataz with Reyataz alone in treatment-naïve patients infected with HIV-1. Reyataz was approved by the FDA in 2003 for use in combination with other antiretroviral agents and is indicated for the treatment of HIV-1 infection in treatment-naïve and -experienced adults and paediatric patients six years of age or older.
In 2011, Bristol-Myers Squibb licensed rights to develop and market a once-daily tablet combining Reyataz and cobicistat. Under the agreed terms, Bristol-Myers Squibb holds global responsibility for developing and commercialising the combination of Reyataz and cobicistat. Meanwhile, Gilead retains exclusive rights for the development and commercialisation of cobicistat as a monotherapy and in combination with other drugs. Earlier this month, Johnson & Johnson's Janssen Research & Development unit filed for FDA approval of a once-daily fixed-dose combination tablet of the protease inhibitor Prezista (darunavir) and cobicistat.
For further information on the HIV market, see Therapy Trends: HIV - Single-tablet complete regimens drive growth.
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