2014年11月27日，强生（JNJ）旗下杨森（Jassen）近日宣布，欧盟委员会（EC）已批准HIV复方药Rezolsta（darunavir/cobicistat）联合其他抗逆转录病毒(ARV)药物，用于18岁及以上人类免疫缺陷病毒-1（HIV-1）成人感染者的治疗。此前，该复方单片（darunavir/cobicistat）已获加拿大批准，品牌名为Prezcobix；目前，该药也正在接受FDA的审查。
Rezolsta是一种新的每日一次的单一片剂固定剂量抗逆转录病毒复方药物，消除了服用darunavir时需再服药效增强剂的必要性。
同时，欧盟已批准蛋白酶抑制剂Prezista（darunavir，达芦那韦）2个标签适应症扩展：（1）批准每日一次剂量darunavir/ritonavir联合其他ARV用于3-12岁ARV初治儿科群体，增加了darunavir用于儿科群体的便利性；（2）批准cobicistat作为darunavir的一种备用增效剂，联合其他ARV用于18岁及以上患者群体，为darunavir用于这类患者提供了另一种增效选择。
强生于2013年10月向欧洲药品管理局（EMA）提交了Rezolsta的上市许可申请（MAA），并于今年9月获得了欧盟人用医药产品委员会（CHMP）建议批准的积极意见，CHMP同时建议批准蛋白酶抑制剂Prezista（darunavir，达芦那韦）的2个标签适应症扩展。
Prezista（darunavir，达芦那韦）是杨森开发的一种蛋白酶抑制剂，该药常与一种药效增效剂ritonavir及其他HIV药物联合用药。
Tybost（cobicistat）是吉利德（Gilead）开发的一种药效动力学增强剂，于2013年9月获欧盟批准，该药每日口服一次，用于提高特定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
Generic Name: darunavir + cobicistat
Trade Name: Rezolsta (EU), Prezcobix (US)
Entry Type: New formulation
Development and Regulatory status
UK: Launched
EU: Launched
US: Approved (Licensed)
UK launch Plans: Available only to registered users
Actual UK launch date: December 2014
Comments
Feb 15: Approved in the US [7].
03/02/2015 16:04:35
Dec 14: Launched in the UK [6].
17/12/2014 12:02:11
Nov 14: European Commission has approved REZOLSTA® (darunavir/cobicistat) in combination with other antiretrovirals (ARV) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older [5].
26/11/2014 14:57:28
Sep 14: EU positive opinion for treatment of antiretroviral therapy (ART)-naïve adults and ART-experienced adults with no darunavir (DRV) resistance associated mutations (RAMs) [4].
29/09/2014 12:06:57
Apr 14: Filed in the US. If approved, the fixed-dose combination pill will be marketed under a new brand name by Janssen [3].
02/04/2014 12:00:28
Oct 13: A Marketing Authorisation Application has been submitted to the EMA seeking approval for a once-daily single tablet fixed-dose containing darunavir with cobicistat for use in combination with other HIV-1 medicines. [2]
16/10/2013 16:08:44
Jan 13: PIII in US & EU [1].
05/03/2013 10:20:56
Trial or other data
According to Johnson & Johnson, 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 [3].
02/04/2014 12:00:51
Evidence Based eva luations
EPAR http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002819/WC500178955.pdf
References
Available only to registered users
Category
BNF Category: Antiviral drugs (05.03)
Pharmacology: Protease inhibitor & pharmacoenhancing agent - increases systemic levels of coadministered agents that are metabolised by CYP3A
Epidemiology: An estimated 83,000 people were living with HIV in 2008 in the UK; about 27% were unaware of their infection. In 2008, there were 7,298 new diagnoses of HIV.
Indication: HIV infection
Additional Details: in treatment-naive & experienced pts
Method(s) of Administration
Oral
Company Information
Name: Janssen-Cilag
US Name: Janssen-Cilag
Further Information
Anticipated Commissioning route (England) NHSE
In timetable: -
PbR Yes
Comments |
