Navigation Links
Newly Approved HIV Drug Shows Great Promise
Date:1/30/2008

Pricing Level Should Improve Access

WASHINGTON, Jan. 30 /PRNewswire/ -- The AIDS Institute, a national public policy research, advocacy, and education organization, is encouraged with the FDA's approval of the first new non-nucleoside reverse transcriptase inhibitor (NNRTI) in nearly a decade. TMC125/etravirine was developed by Tibotec Pharmaceuticals, Ltd. and will be marketed in the U.S. by Tibotec Therapeutics as Intelence(R), a division of Ortho Biotech Products, L.P. The company announced introductory pricing for the new NNRTI at $21.80 per day, which is substantially lower than other recently introduced antiretrovirals.

In a Title II Community AIDS National Network release dated January 19, 2008, Dr. Donna Christian-Chistensen, Chair of the Congressional Black Caucus Health Brain Trust stated: "The efficacy that Intelence (TMC125/etravirine) has shown in the DUET studies is impressive. Intelence is an important new HIV medication that, for the first time, re-opens the NNRTI class to patients with NNRTI-resistant virus. We applaud Tibotec for its efforts to make this innovative new medication available and accessible to people living with HIV."

The U.S. Food and Drug Administration (FDA) granted accelerated approval to the anti-HIV medication. This is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment- experienced adult patients with HIV resistant to an NNRTI and other antiretroviral (ARV) agents. Intelence, in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment- experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other ARV agents. This indication is based on Week 24 analyses from two randomized, double-blind, placebo-controlled trials of Intelence. Both studies were conducted in clinically advanced, three-class antiretroviral (NNRTI, N[t]RTI, PI) treatment-experienced adults.

Accelerated approval is a regulatory mechanism that allows earlier approval of drugs used to treat serious or life-threatening conditions, based on surrogate endpoints that demonstrate meaningful therapeutic advantage over existing treatment. Accelerated approval is based on evidence of a drug's effect on a surrogate endpoint that reasonably suggests clinical benefit. Accelerated approval requires any necessary studies to establish and define the degree of clinical benefit to patients be completed before traditional approval can be granted.

Dr. Gene Copello, Executive Director of The AIDS Institute, stated: "We appreciate the FDA's accelerated approval process to encourage further research and development of new life-saving medications. Tibotec is to be applauded for this development including the company's attempt to make this new drug accessible."

For more information and to become involved in AIDS advocacy work, please contact The AIDS Institute at: (202) 835-8373, or by email at: Info@theaidsinstitute.org or http://www.TheAIDSInstitute.org

The AIDS Institute is a national nonprofit agency that promotes action for social change through public policy research, advocacy and education.


'/>"/>
SOURCE The AIDS Institute
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Millennium Initiates Clinical Trial to EVOLVE the Treatment of Patients with Newly Diagnosed Multiple Myeloma
2. Sixty-One Percent of Newly Diagnosed Parkinsons Disease Patients Do Not Receive Any Drug Treatment in the First Year of Diagnosis
3. Phase III Clinical Trial in Newly Diagnosed Multiple Myeloma Stopped Early Due to Highly Significant Efficacy Advantage of VELCADE(R) (Bortezomib) for Injection Based Therapy Across All Endpoints
4. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
5. New Data to Support VELCADE(R) (Bortezomib) For Injection Based Therapies as Setting New Standards in The Care of Newly Diagnosed Patients With Multiple Myeloma
6. Oncology Drugs Development Update - Worldwide Markets and Forecasts of Approved EGFr/HEr2 Inhibitors, Treatment Costs, Pathway Analysis, Current and Expanded Clinical Indications, and Novel Agents in Development
7. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
8. Norditropin(R) Approved for Treatment of Children with Short Stature Associated with Turner Syndrome
9. Nexavar First FDA-Approved Drug Therapy for Liver Cancer
10. Iomai Trial Shows 100 Percent Immune Response in Elderly Subjects Vaccinated With Novel Travelers Diarrhea Patch Vaccine
11. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/22/2017)... VALLEY COTTAGE, N.Y. , May 22, 2017 ... natural antiviral treatment Gene-Eden-VIR/Novirin, announces the launch of ... in plain English, the results of a clinical ... after one year treatment with Gene-Eden-VIR/Novirin in individuals ... is important to note that there are no ...
(Date:5/18/2017)... -- Bayer announced today that the latest research from across ... 53 rd Annual Meeting of the American Society ... Chicago . The ... and thyroid cancers, as well as lymphomas, and includes ... of copanlisib in patients with relapsed or refractory follicular ...
(Date:5/12/2017)... Canada joint tech company Laughing Face has developed ... and features a powerful disinfection process. The company has ... and sanitizes women,s panties or babies, cloth diapers in 25 minutes. ... Laughing ... external water inlet. ...
Breaking Medicine Technology:
(Date:5/28/2017)... ... May 28, 2017 , ... Viewers likely know Rob Lowe from ... is also noted for his work on NBC’s The West Wing and Parks and ... the new series “Informed,” which puts the spotlight on important modern-day issues that face ...
(Date:5/27/2017)... ... , ... In any business, follow up is critical to success. It is ... presenting treatment, there will always be some patients who can’t or won’t make a ... practices when it comes to presenting treatment. After the patient leaves, most practices ...
(Date:5/26/2017)... ... May 26, 2017 , ... Mediaplanet is proud to announce ... in USA Today, which will educate readers on how to take care of all ... large focus is placed on melanoma. Dancing with the Stars professional, Witney Carson, shares ...
(Date:5/26/2017)... ... May 26, 2017 , ... ... a new educational seminar to focus on current legislative activity and the latest ... begin at 1 p.m. Sunday, Sept. 10, and will continue through Monday, Sept. ...
(Date:5/26/2017)... ... May 26, 2017 , ... A new analysis of community ... healthiest seniors are located in the Midwest. With the average cost of healthcare rising ... are concerned with both the quality and affordability of where they live. An annual ...
Breaking Medicine News(10 mins):