A Smart + Strong Site
Subscribe to:
E-newsletters
POZ magazine
JOIN AIDSMEDS YouTube

Back to home » Treatment News » Top Stories

Most Popular Stories
Undetectable Viral Load Essentially Eliminates Transmission Risk in Straight Couples
A 15-Year Jump in Life Expectancy for People With HIV
Life Expectancy for Young People With HIV Is Nearly Normal
Failure to Awaken Dormant Cells Deals Blow to HIV Cure Research
Scientists Devise Method of Snipping HIV From Immune Cells
Media Cooks Up Claim That Soy Sauce Treats, Even Cures HIV
FDA Approves New Single-Tablet HIV Regimen, Triumeq
What's That Mean?
(just double-click it!)

If you don't understand one of the words in this article, just double-click it. A window will open with a definition from mondofacto's On-line Medical Dictionary. If the double-click feature doesn't work in your browser, you can enter the word below:

Most Popular Lessons
Aging & HIV
The HIV Life Cycle
Shingles
Herpes Simplex Virus
Syphilis & Neurosyphilis
Treatments for Opportunistic Infections (OIs)
What is AIDS & HIV?
More News

Have medical or treatment news about HIV? Send press releases, news tips and other announcements to news@aidsmeds.com.

Click here for more news


emailprint

June 28, 2012

Approval Application for Gilead’s Novel Booster Cobicistat Filed with FDA

A day after Gilead Sciences filed a New Drug Application (NDA) for its integrase inhibitor elvitegravir, the company announced on June 28 that it has submitted the necessary paperwork to the U.S. Food and Drug Administration requesting approval for its experimental pharmacoenhancing agent cobicistat (GS-9350).

If found to be safe and effective by the agency, cobicistat may be given marketing clearance to be used in combination with various antiretroviral medications, notably Reyataz (atazanavir) and Prezista (darunavir), as an alternative to low-dose Norvir (ritonavir) to boost their blood levels and allow for simplified dosing.

The company’s “Quad” fixed-dose combination tablet—containing cobicistat, the experimental integrase inhibitor elvitegravir, and the nucleoside reverse transcriptase inhibitors tenofovir and emtricitabine—was recently recommended for approval by the FDA’s Antiviral Drugs Advisory Committee for people living with HIV starting ARV therapy for the first time.

The NDA for cobicistat, supporting its use as a separate drug in combination with approved ARVs, is based on 48-week data from a Phase III study in which the agent was found to be comparable to Norvir when both boosters were administered with a background regimen of Reyataz plus Truvada (emtricitabine plus tenofovir).

The application is also supported by data demonstrating that cobicistat boosts blood levels of atazanavir and darunavir similar to ritonavir.

Gilead entered into an agreement with Janssen Therapeutics in June 2011 for the development of a fixed-dose combination tablet containing cobicistat and Prezista. In October 2011, Gilead announced an agreement with Bristol-Myers Squibb to develop a fixed-dose combination of cobicistat and Reyataz.

Search: cobicistat, gilead, booster, ritonavir, norvir, prezista, reyataz, nda, approval, fda


Scroll down to comment on this story.



Name:

(will display; 2-50 characters)

Email:

(will NOT display)

City:

(will display; optional)

Comment (500 characters left):

(Note: The AIDSmeds team reviews all comments before they are posted. Please do not include ":" "@" "<" ">" in your comment. The opinions expressed by people providing comments are theirs alone. They do not necessarily reflect the opinions of Smart + Strong, which is not responsible for the accuracy of any of the information supplied by people providing comments.)

Comments require captcha.
Please enter this number for verification:

| Posting Rules



Show comments (0 total)


[Go to top]

Quick Links
AIDSmeds en Español
About HIV and AIDS
Lab Tests
Clinical Trials
HIV Meds
Starting Treatment
Switching Treatment
Drug Resistance
Side Effects
Disclosure
Lipodystrophy
Hepatitis & HIV
Women & Children
Fact Sheets
Treatment News
Community Forums
Blogs
Conference Coverage
Health Services Directory
POZ Magazine


    Hillcrester
    Ramona
    California


    Poz_Qt
    Columbus
    Ohio


    Fred9774
    Brooklyn
    New York


    RayOctober
    Richmond
    Virginia
Click here to join POZ Personals!
Conference Coverage

XX International AIDS Conference
(AIDS 2014)
Melbourne, Australia
July 20 - 25, 2014


21st Conference on Retroviruses and Opportunistic Infections
(CROI 2014)
Boston, MA
March 3 - 7, 2014


7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention
(IAS 2013)
Kuala Lumpur, Malaysia
June 30 - July 3, 2013


more conference coverage

[ about AIDSmeds | AIDSmeds advisory board | our staff | advertising policy | advertise/contact us]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.