Navigation Links
European Committee for Human Medicinal Products (CHMP) Issues Positive Opinion for Once-Daily PREZISTA(R) (Darunavir) as Part of Combination Therapy for Treatment-Naive Adults With HIV-1
Date:11/27/2008

CORK, Ireland, November 27 /PRNewswire/ -- The Committee for Human Medicinal Products (CHMP) has issued a positive opinion recommending approval for once-daily dosing of 800 mg PREZISTA(R) (darunavir) with low-dose ritonavir as part of combination therapy in treatment-naive adults (those who have never taken HIV medication before). Darunavir, a protease inhibitor, was developed by Tibotec Pharmaceuticals, and Tibotec, a division of Janssen-Cilag, is the organisation responsible for marketing the brand in Europe.

The positive opinion from the CHMP, the committee responsible for the scientific assessment of new medicinal products, will be reviewed by the European Commission, which then has authority to approve medicines for use throughout the European Union.

The CHMP's positive opinion is based on 48-week analyses of plasma HIV RNA levels and CD4+ cell counts from the ongoing, randomised, controlled, open-label phase III trial ARTEMIS in antiretroviral treatment-naive HIV-1-infected adults. Patients received 800 mg darunavir once daily with 100 mg ritonavir as part of combination therapy.

Darunavir, co-administered with low dose ritonavir, is currently indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infection in highly pre-treated adult patients who failed more than one regimen containing a protease inhibitor (PI). Darunavir was given conditional approval by the European Commission in February 2007. The full marketing authorisation from the European Commission for treatment-naive adult patients is expected in the coming months.

Important Safety Information

In the registrational studies, darunavir was generally well tolerated versus the investigator selected PIs. The majority of the adverse reactions reported in patients who initiated therapy with darunavir 600 mg co-administered with 100 mg ritonavir twice daily were mild to
'/>"/>

SOURCE Tibotec Pharmaceuticals
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine news :

1. Natural Nutrition Canadian Subsidiary Signs $50.5 Million (CDN) Five Year European Distribution Contract
2. Intellect Neurosciences, Inc. Validates Pivotal European Patent for Alzheimers Monoclonal Antibody Platform
3. Frost & Sullivan Honours GELITA for Developing European Health Ingredient of the Year
4. Cepheid Launches First On-Demand Molecular Diagnostic Test for Clostridium Difficile Into European Market
5. Misys Wins Best Trade Processing Product Accolade in European Banking Technology Readers Choice Awards
6. Stars to Tell It Like It Is at MTVs European Music Awards
7. CPC Appoints Medical Product Service GmbH as Authorized European Representative for MedClose(TM) System
8. ATS Medical Products Featured Prominently in Scientific Presentations at European Association for Cardio-Thoracic Surgeons (EACTS) Annual Meeting
9. Hoana Medical Acquires CE Mark to Expand Patient Safety Technology to European Market
10. Frost & Sullivan Honours Redsense Medical With the 2008 European Hemodialysis Emerging Company of the Year Award
11. Cymbalta Receives European Approval for the Treatment of Generalised Anxiety Disorder
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/15/2014)... SUNDAY, Dec. 14, 2014 (HealthDay News) -- Expert pilots ... which explains why they make better decisions during landings, ... the most difficult techniques for pilots to master, and ... of fatal crashes occur during final approach and landing. ... pilots and 12 moderately experienced pilots while they were ...
(Date:12/15/2014)... Kathy McAfee, America's Marketing Motivator, was ... in the category of Best Blog 2014. McAfee received ... weekly career blog Networking Ahead which combines ... elevate their talent and influence through better networking, leadership ... book Networking Ahead for Business, has been motivating readers ...
(Date:12/15/2014)... Portland, OR (PRWEB) December 15, 2014 ... NAIRO seeks to bring attention to restrictive state ... new position paper on this important area of ... State Laws Can Compromise the Integrity of Independent ... quality and access of independent peer review determinations ...
(Date:12/15/2014)... Bacteroides is becoming the indicator of choice for assessing ... than coliforms, it cannot reproduce in the presence of oxygen ... Benefits of the new Bacteroides Sewage Screen:, ... false positives from coliforms naturally occurring in the environment , ... Maintain the same sampling method with results as quick as ...
(Date:12/15/2014)... 2014 For the second year in a ... 30 Coffees of 2014.” Bird Rock Coffee Roasters’ Sumatra Ulos ... Ethiopia at number 10. This is the first year that ... selection is ranked on quality, value, and other aspects, including ... out of 100, and at $17.99 for 12-ounces, was also ...
Breaking Medicine News(10 mins):Health News:Study Shows Why Expert Pilots Are Experts 2Health News:Kathy McAfee, America’s Marketing Motivator, Wins Best Blog from Women World Awards 2Health News:NAIRO Calls for Higher Quality Independent Peer Review By Ending Restrictive State Laws 2Health News:Bird Rock Coffee Roasters Ranks Second and Tenth in Coffee Review’s ‘Top 30 Coffees of 2014’ 2
... April 13 (HealthDay News) -- New data shows that youth ... of football injuries among players aged 6 to 17 who ... over 18 years, from 274,094 in 1990 to 346,772 in ... were an estimated 5.25 million football-related injuries among youngsters in ...
... aid treatment of learning impairments, strokes, tinnitus and chronic ... stimulation accelerates learning in laboratory tests. Another major ... issue of Neuron , involves the positive changes ... brain activity in rats found that brain responses eventually ...
... faced with more than the demise of a political system. ... a 40 percent surge in deaths between 1990 and 1994. ... clear. And for years, many economists and political scientists have ... men to drink. They reasoned that privatization left many people ...
... equals good, happy, optimistic; down the opposite. Right is ... language and culture tell us. "We use mental metaphors ... Daniel Casasanto, "One of those metaphors is space." ... Casasanto has found. Rather, "people associate goodness with the ...
... 2011 Elsevier, the leading publisher of scientific, ... announced the launch of Methods Navigator. This online ... and apply the right method for their research, ... joins Elsevier,s stable of workflow solutions including Hazmat ...
... Jenifer Goodwin HealthDay Reporter , WEDNESDAY, April 13 ... autism last December, Kristen Paurus and her husband, Bill, sought ... hometown of Sebeka, Minn., population 710, that,s not easy. ... their daughter, Brea, makes with her dad twice a week. ...
Cached Medicine News:Health News:Youth Football Injuries on the Rise, Study Finds 2Health News:Making temporary changes to brain could speed up learning, study reports 2Health News:Making temporary changes to brain could speed up learning, study reports 3Health News:Stanford research casts sober light on Russia's mortality crisis 2Health News:Stanford research casts sober light on Russia's mortality crisis 3Health News:Are your values right or left? The answer is more literal than you think 2Health News:'Best' Places to Live With Autism All in Major Metro Areas: Survey 2Health News:'Best' Places to Live With Autism All in Major Metro Areas: Survey 3
(Date:12/15/2014)... BOSTON , December 15, 2014 ... and development company, is pleased to announce the grant ... States relating to its GPCR-focused drug discovery ... significantly strengthens the global patent estate covering Heptares, technologies ... The suite of patents recently granted by the US ...
(Date:12/13/2014)... , Dec. 12, 2014  Radiologists can ... to images, to their referring physicians, electronic health ... using carefully selected technology.  That ... Data Systems Corporation (ADS) at the recent Radiology ... The transmitting of radiology reports in this manner ...
(Date:12/13/2014)... PLAINSBORO, N.J. and INDIANAPOLIS , ... diabetes care, and Chip Ganassi Racing Teams (CGRT), today announced ... Nordisk as the primary sponsor of the No. 83 Novo ... in the Verizon IndyCar Series. Kimball, ... first and only licensed driver with diabetes in the history ...
Breaking Medicine Technology:Heptares Extends Global Patent Protection for GPCR-Focused Drug Discovery Platform With Grant of Core Patents in the United States 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 2Advanced Data Systems Presents on Interface-Free EHR Communications at RSNA's 2014 Conference: Streamlining Communication of Reports and Images to Referring Physicians 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 2Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 3Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 4Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 5Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 6Novo Nordisk and Chip Ganassi Racing Teams Announce Multi-Year Sponsorship Agreement for Verizon IndyCar Series 7
... LTD. announced on August 20 that its collaborative study on ... Cholera and Enteric Diseases in Kolkata, India, showed that daily ... diarrhea in young children. An unprecedented large-scale study, ... Kolkata, was conducted. As a result, "Yakult" was shown to ...
... inflammation plays a surprising role reducing the level of infection caused ... patients and others with weakened immune systems. The drug, ... by enhancing the body,s ability to chew them up instead of ... to provoke an onslaught of harmful inflammation. Besides opening ...
Cached Medicine Technology:Daily Intake of 'Yakult' Is Efficacious in Reducing Incidence of Acute Diarrhea in Young Children 2Daily Intake of 'Yakult' Is Efficacious in Reducing Incidence of Acute Diarrhea in Young Children 3Old Drug Holds Promise Against Opportunistic Lung Bug 2Old Drug Holds Promise Against Opportunistic Lung Bug 3Old Drug Holds Promise Against Opportunistic Lung Bug 4
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
Medicine Products: