Navigation Links
ViiV Healthcare announces US regulatory submission for a single-tablet regimen combining dolutegravir with abacavir and lamivudine for people living with HIV
Date:10/22/2013

LONDON, Oct. 22, 2013 /PRNewswire/ -- ViiV Healthcare today announced the submission of a regulatory application in the United States for its investigational single-tablet regimen (STR) combining dolutegravir, abacavir and lamivudine for the treatment of people living with HIV-1. This New Drug Application (NDA) follows the approval of dolutegravir by the US Food and Drug Administration (FDA) in August 2013 under the brand name Tivicay®, approved for use in combination with other antiretroviral agents for the treatment of HIV-1 in adults and children aged 12 years and older weighing at least 40 kg (approx. 88 lbs).

"People living with HIV and their doctors seek to use appropriate treatment options for the individual, while also trying to minimise the number of pills required for effective and acceptable antiretroviral treatment," said Dr John Pottage, Chief Medical Officer, ViiV Healthcare. "This submission aims to make a complete Tivicay-based regimen available for the first time in a single once-daily pill."

In Europe, a Marketing Authorisation Application (MAA) for this single-tablet regimen will be submitted in the near future. The review of the MAA for dolutegravir (DTG), submitted in Europe in December 2012, is in progress with the European Medicines Agency (EMA). A combination tablet containing abacavir (ABC) and lamivudine (3TC) is approved and available in the US under the brand name Epzicom® (abacavir sulfate 600 mg + lamivudine 300 mg) and in the EU under the brand name Kivexa®.

The investigational single-tablet combination of DTG/ABC/3TC has sometimes been referred to as "Trii".  The submission announced today is based on data from one pivotal Phase III study of DTG1, supported by three other Phase III/IIIb studies2-4, which ev
'/>"/>

SOURCE ViiV Healthcare
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Global Healthcare Leader Deploys QUOSAs Literature Management Tools
2. Sysmex America Leads Educational Offerings Focused on Healthcare Reforms Impact on the Clinical Laboratory
3. Hyland Software Partners with the Global Center for Healthcare Innovation in Cleveland
4. Allied Healthcare Products Reports Loss On Sales Decline
5. 50 Years Old and Still Bounding Over the Counter: Klines Healthcare Practice Continues to Deliver Unmatched OTC Market Intelligence
6. Experian Healthcare launches tool to enable providers to identify and help enroll eligible individuals for health insurance exchange (HIX) subsidized programs
7. BioSpecifics Technologies Corp. to Present at the Aegis Capital 2013 Healthcare Conference
8. Orange County Hospital System, Integrated Healthcare Holdings, Joins ApolloMed ACO
9. ViiV Healthcare Presents Positive Data from Phase IIIb/IV Study of Dolutegravir vs Darunavir in Treatment-Naive Adults with HIV-1
10. Hubble Telemedical Welcomes Healthcare Visionary Jonathan Lord, M.D. to Its Board of Directors
11. Piramal
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/22/2014)... , Oct. 22, 2014 AVACEN Medical ... device received 510 (k) OTC clearance by the U.S. ... 100 to be marketed over the Internet for: ... muscle spasms; and minor strains and sprains . ... The AVACEN 100 (MSRP $2495) is a sophisticated medical ...
(Date:10/22/2014)... -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) ... focused on the development of oral drug delivery ... its Phase IIa clinical trial of ORMD-0801, the ... 1 diabetes. The trial was conducted in ... Food and Drug Administration (FDA) Investigational New Drug ...
(Date:10/22/2014)... Influenza will affect as many as 200,000 people ... United States as high as 49,000 people.  The ... from person to person in respiratory droplets of coughs and ... death, but kills much fewer people each year than the ... fluids including sweat, saliva, blood and other bodily fluids. The ...
Breaking Medicine Technology:AVACEN Medical Announces FDA Clearance of First Medical Device with Internal Game Mode 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 2Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 3Oramed Pharmaceuticals Reports Positive Top-Line Data from U.S. Phase IIa Trial with Oral Insulin in Type 1 Diabetes 4WholeHealth Products is proud to be releasing its Influenza A and B combo test, on the heels of the announcing of its phase 2 completion of the Rapid Ebola Test 2
... 2 Meeting with the FDA for the Fabry Program and Initiation ... ... Quarter, CRANBURY, N.J., Aug. 7 ... pharmacological chaperones for the treatment of human,genetic diseases, today announced financial results ...
... 7 The American Association of Diabetes,Educators ... conducted by Harris,Interactive highlighting communication between people ... healthcare providers. According to the,survey results, 33 ... of,dread relating to insulin injections (eight percent ...
Cached Medicine Technology:Amicus Therapeutics Announces Second Quarter 2008 Financial Results 2Amicus Therapeutics Announces Second Quarter 2008 Financial Results 3Amicus Therapeutics Announces Second Quarter 2008 Financial Results 4Amicus Therapeutics Announces Second Quarter 2008 Financial Results 5Amicus Therapeutics Announces Second Quarter 2008 Financial Results 6Amicus Therapeutics Announces Second Quarter 2008 Financial Results 7Amicus Therapeutics Announces Second Quarter 2008 Financial Results 8Amicus Therapeutics Announces Second Quarter 2008 Financial Results 9Amicus Therapeutics Announces Second Quarter 2008 Financial Results 10Amicus Therapeutics Announces Second Quarter 2008 Financial Results 11Amicus Therapeutics Announces Second Quarter 2008 Financial Results 12New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers 2New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers 3New Survey Explores the Impact of Insulin Injections and Communications Between Patients and Healthcare Providers 4
(Date:10/22/2014)... 22, 2014 Akeso Biomedical, Inc. ... the treatment of bacterial infections, microbial biofilms, and chronic ... its board of directors. , Dr. Sinskey ... at The Massachusetts Institute of Technology, or MIT. He ... 1968. Dr. Sinskey also holds positions as Co-Director of ...
(Date:10/22/2014)... Haelle HealthDay Reporter , TUESDAY, ... adult men may lead to increased blood pressure, according to ... similar rise in blood pressure for young adult women or ... adult women drank lightly or moderately, their risk of high ... "This finding parallels studies in older adult men and women," ...
(Date:10/22/2014)... HealthDay Reporter TUESDAY, Oct. 21, 2014 (HealthDay News) ... for NBC News in Liberia has cleared the virus ... Nebraska Medical Center in Omaha, where he had been treated for ... test confirmed by the U.S. Centers for Disease Control and Prevention ... NBC News reported Tuesday night. "Recovering from Ebola ...
(Date:10/20/2014)... The Advocator Group, LLC is proud ... for Suicide Prevention’s (AFSP) Out of the Darkness walk ... that hosts hundreds of community walks throughout the country ... to help understand and prevent suicide through not only ... , The Advocator Group shares this passion for ...
(Date:10/20/2014)... IN (PRWEB) October 20, 2014 ... Start, a secure cloud solution that enables healthcare ... of the ultimate healthcare-specific customer relationship management (“CRM”) ... meet the unique needs of the healthcare industry, ... experience for providers and patients by combining healthcare ...
Breaking Medicine News(10 mins):Health News:Akeso Biomedical Appoints Dr. Anthony J. Sinskey to Board of Directors 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 2Health News:Binge Drinking May Boost Blood Pressure in Young Men 3Health News:Binge Drinking May Boost Blood Pressure in Young Men 4Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 2Health News:U.S. Cameraman Treated for Ebola 'Free' of the Virus 3Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 2Health News:The Advocator Group, LLC is Proud to Participate in an Out of the Darkness Community Walk, October 25th, to Increase Suicide Awareness 3Health News:Healthcare Relationship Management (HRM) Leader hc1.com® Launches hc1® Quick Start™ 2
... , , , CARLSBAD, Calif., ... the leader in antisense therapeutics, today announced that management will present ... Conference on Tuesday, August 11, 2009, at 1:00 p.m. ET at ... audio webcast of the presentation will be available on the "Investors ...
... , , SPRING, ... pleased to advise the nutrition and investing community that its flagship ... corporate activities, are easily accessible by simply Googling Cholesterade(R). , ... recent updates on Go Healthy and/or its products, we are confident ...
... , , , , ... high-performance sports water , is targeting ... of major sporting events throughout the late summer and fall. ... cellular hydration in the most demanding environments, from professional sporting events ...
... ... UK have brought every major video conference endpoint manufacturer together for the ultimate in ... altogether under one roof and connect with MCU, Gateway, Firewall, Streaming & Recording infrastructure ... ...
... ... Web site with resources for people with disabilities coincides with Americans with Disabilities Act,s ... ... Americans with Disabilities Act, the U.S. Department of Labor has re-named and re-launched its ...
... , , WASHINGTON, ... announced that they have been chosen as the exclusive ... improvement program, called the IC3 Program(R) (Improving Continuous Cardiac ... Record (EHR) interfacing and data extraction process beginning with ...
Cached Medicine News:Health News:Go Healthy's Marquis Product Cholesterade(R) at Your Fingertips on Google 2Health News:AquaHydrate, First High Performance Sports Water, Targets So Cal Sports Market With Summer Event Support 2Health News:AquaHydrate, First High Performance Sports Water, Targets So Cal Sports Market With Summer Event Support 3Health News:The World of HD Video Conferencing is Now at VideoCentric - One-stop Comparisons of Tandberg, Polycom, Lifesize, Sony, Emblaze-VCON and Aethra 2Health News:The World of HD Video Conferencing is Now at VideoCentric - One-stop Comparisons of Tandberg, Polycom, Lifesize, Sony, Emblaze-VCON and Aethra 3Health News:The World of HD Video Conferencing is Now at VideoCentric - One-stop Comparisons of Tandberg, Polycom, Lifesize, Sony, Emblaze-VCON and Aethra 4Health News:Disability.gov Adds Social Media Tools, Disability Resources and a New Design to Complement Information from 22 Federal Agencies 2Health News:Disability.gov Adds Social Media Tools, Disability Resources and a New Design to Complement Information from 22 Federal Agencies 3Health News:Featherstone Informatics Group, Inc. Named Exclusive Vendor for the American College of Cardiology's Practice-Based Data Registry Program 2
Curved shafts with 2 mm angled platform. Wide serrated handle with dull finish....
Curved shafts with 3.5 mm angled platform and dull finish. Wide serrated handle with dull finish....
15 mm curved blade. 8 mm straight distal tip. Serrated on top of knife. Flat handle....
Grooved roller, on which knife oscillates....
Medicine Products: