2016年2月26日，美国生物技术巨头吉利德（Gilead）艾滋病管线近日在欧盟监管方面传来喜讯，欧洲药品管理局（EMA）人用医药产品委员会（CHMP）支持批准HIV复方新药F/TAF（emtricitabine/tenofovir alafenamide，恩曲他滨/替诺福韦艾拉酚胺，200/10mg和200/25mg），联合其他HIV抗逆转录病毒药物用于HIV-1成人感染者，以及12岁及以上且体重至少35千克的HIV青少年感染者。
欧盟委员会（EC）在药品审查时，通常都会采纳CHMP的建议，这意味着HIV复方新药F/TAF很可能在2-3个月内获批上市，造福欧洲的HIV-1患者群体。如果获批，F/TAF将以品牌名Descovy上市销售。
New Drugs Online Report for emtricitabine + tenofovir alafenamide
Information
Generic Name: emtricitabine + tenofovir alafenamide
Trade Name: Descovy
Synonym: F/TAF
Entry Type: New formulation
Development and Regulatory status
UK: Recommended for approval (Positive opinion)
EU: Recommended for approval (Positive opinion)
US: Pre-registration (Filed)
UK launch Plans: Available only to registered users
Actual UK launch date:
Comments
Feb 16: EU positive opinion for use in combination with other antiretroviral agents for treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with HIV 1 [4].
26/02/2016 12:34:09
May 15: MA submitted to EMA for fixed-dsoe combination of emtricitabine and tenofovir alafenamide for HIV treatment [3].
02/06/2015 10:22:09
Apr 15: PIII in Belgium, Canada, France, Italy, Puerto Rico and the UK; Gilead plans to submit a regulatory application for F/TAF in the EU in Q2 2015 [1,2].
08/04/2015 13:29:05
Apr 15: A New Drug Application filed with the US FDA seeking approval to market two strengths of a fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for HIV-1 infection in patients aged 12 years and older, alongside other antiretrovirals [1].
08/04/2015 13:27:42
Trial or other data
Sep 15: Gilead Sciences announce that investigational fixed-dose combination of F/TAF meets primary 48-233k objective in PIII study. FTC/TDF-based regimes achieved similar rates of virologic suppression based on proportion of patients with HIV RNA levels (viral load) <50copies/mL (94.3% F/TAF vs. 93% RDF-regimens [4].
04/09/2015 10:41:39
May 14: Gilead Sciences initiates a randomised, double-blind PIII trial of emtricitabine 200mg/tenofovir alafenamide 10 or 25mg (F/TAF) single tablet formulation in patients with HIV-1 infections, who are virologically suppressed on emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) containing regimens (NCT02121795; EudraCT2013-005138-39). Primary endpoint of the trial is the proportion of patients with HIV-1 RNA < 50 copies/ml at week 48 as determined by the FDA snapshot analysis. The trial will enrol approximately 660 patients in the US, Belgium, Canada, France, Italy, Puerto Rico and the UK. Patients will receive either emtricitabine 200mg/tenofovir alafenamide 10 or 25mg plus placebo or emtricitabine 200mg/tenofovir disoproxil fumarate 300mg plus placebo, along with an allowed antiretroviral agent from the patient´s pre-existing treatment regimen [2].
08/04/2015 13:30:00
References
Available only to registered users
Category
BNF Category: HIV infection (05.03.01)
Pharmacology: A fixed dose combination (FDC) of emtricitabine and tenofovir alafenamide (F/TAF), as a single tablet formulation, for the treatment of HIV infections. The FDC acts as a nucleoside and nucleotide reverse transcriptase inhibitor.
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-experienced patients aged 12 years and older, in combination with other antiretrovirals
Method(s) of Administration
Oral
Company Information
Name: Gilead Sciences
US Name: Gilead Sciences
Further Information
Anticipated commissioning route (England) NHSE
High cost drug list? Awaiting Update
Implications Available only to registered users |
