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FDA接受审查吉利德cobicistat和elvitegravir新药申请
发表时间:2014-04-23

2014年4月23日讯 /生物谷BIOON/ --吉利德科学(Gilead Sciences)4月21日宣布,FDA已接受该公司提交的cobicistat和elvitegravir 2个新药申请(NDA)。FDA已指定cobicistat和elvitegravir处方药用户收费法目标审查日期为2014年10月3日和4日。

cobicistat是一种药效动力学增强剂,商品名为Tybost,于2013年9月25日获欧盟批准,作为每日一次的药代动力学增强剂,提高特定HIV药物的血药浓度。Tybost旨在作为HIV蛋白酶抑制剂阿扎那韦(atazanavir,300mg,每天一次)和地瑞那韦(darunavir,800mg,每天一次)的增强剂,作为抗逆转录病毒联合疗法的一部分,用于HIV-1成人感染者的治疗。

elvitegravir是一种HIV整合酶抑制剂,商品名为Vitekta,于2013年11月18日获欧盟批准,用于无任何已知elvitegravir抗性相关突变的HIV-1成人感染者的治疗。Vitekta旨在用作HIV治疗方案的一部分。Vitekta通过阻断病毒整合至人体细胞基因组,干扰HIV病毒的复制。在临床试验中,Vitekta在感染HIV抗药株的患者群体中,能够有效抑制HIV病毒。

吉利德于2012年6月向FDA提交了cobicistat和elvitegravir的新药申请。

cobicistat和elvitegravir是吉利德四合一型HIV新药Stribild(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine(恩曲他滨) 200 mg/tenofovir(泰诺福韦) disoproxil (as fumarate) 245 mg)的组成部分。Stribild为日服一次的单一片剂,用于HIV-1感染的治疗,该药已于2012年8月获FDA批准。(生物谷Bioon.com)

英文原文:Gilead Sciences’ New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA

-- Final FDA Decisions Anticipated by October 3 and 4, 2014 --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 21, 2014-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s refiling of two New Drug Applications (NDA) for cobicistat, a pharmacoenhancing or “boosting” agent that increases blood levels of the protease inhibitors atazanavir and darunavir to enable once-daily dosing of these medicines in HIV therapy, and elvitegravir, an integrase inhibitor for the treatment of HIV-1 infection in treatment-experienced adults. The FDA has set target review dates under the Prescription Drug User Fee Act (PDUFA) of October 3, 2014 for cobicistat and October 4, 2014 for elvitegravir.

Gilead submitted NDAs for cobicistat and elvitegravir in June 2012. In April 2013, the company received Complete Response Letters from the FDA. In its communications, the agency stated that it could not approve the cobicistat and elvitegravir applications in their current forms, citing deficiencies in documentation and validation of certain quality testing procedures and methods that were observed during inspections. Gilead has worked with the FDA to address the questions raised in the Complete Response Letters.

Cobicistat and elvitegravir are components of Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), a once-daily single tablet regimen for the treatment of HIV-1 infection. Stribild was approved in the United States in August 2012.

Cobicistat is approved under the tradename Tybost® and elvitegravir is approved under the tradename Vitekta® in Europe, Canada and Australia.

About Cobicistat and Elvitegravir

Cobicistat is a cytochrome P450 3A (CYP3A) inhibitor. It boosts blood levels of the HIV protease inhibitors atazanavir and darunavir by suppressing CYP3A, an enzyme that metabolizes these drugs in the body. Cobicistat acts only as a pharmacokinetic enhancer and has no antiviral activity.

Elvitegravir was licensed by Gilead from Japan Tobacco Inc. (JT) in March 2005. Under the terms of Gilead’s agreement with JT, Gilead has exclusive rights to develop and commercialize elvitegravir as a single agent in all countries of the world, excluding Japan, where JT retains rights.

Cobicistat and elvitegravir are investigational products in the United States and their safety and efficacy have not yet been established.

About Gilead Sciences

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia Pacific.

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作者:tomato来源:生物谷