Treatment News : BMS Files for FDA Approval of Reyataz/Cobicistat Combo Pill

POZ - Health, Life and HIV
Subscribe to:
POZ magazine
E-newsletters
Join POZ: Facebook MySpace Twitter Pinterest
Tumblr Google+ Flickr MySpace
POZ Personals
Sign In / Join
Username:
Password:

Back to home » Treatment News » April 2014

Most Popular Links
Most Popular Lessons

The HIV Life Cycle

Shingles

Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

15 Years Ago In POZ


More Treatment News

Click here for more news

Have news about HIV? Send press releases, news tips and other announcements to news@poz.com.


emailprint

April 22, 2014

BMS Files for FDA Approval of Reyataz/Cobicistat Combo Pill

Bristol-Myers Squibb (BMS) has filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for a fixed-dose combination tablet of Reyataz (atazanavir) and cobicistat for the treatment of HIV. The latter drug is an investigational pharmacokinetic enhancer, or boosting agent, that’s similar to Norvir (ritonavir) in that it can increase blood levels of certain antiretrovirals.

Reyataz, a protease inhibitor that was approved in 2003 and has been prescribed to about a quarter of a million people with HIV since then, is often paired with Norvir as a boosting agent.

“Bristol-Myers Squibb is committed to enhancing our existing regimens, as well as developing new therapies to make HIV treatment simpler for patients,” Brian Daniels MD, senior vice president of global development and medical affairs at BMS, said in a release. “The submission of this NDA represents an important step forward in our efforts to provide patients with new options for Reyataz treatment.”

The two drugs were studied in a prospective, randomized, Phase III double-blind clinical trial that compared the safety and efficacy of cobicistat-boosted Reyataz with Norvir-boosted Reyataz in treatment-naive people with HIV over a course of 48 weeks.

“Adhering to HIV treatment regimens can be challenging for some patients, and if the prescribed medications are not taken properly it could result in treatment failure,” Calvin J. Cohen, MD, MPH, director of research at the Community Research Initiative of New England and an internist at Harvard Vanguard Medical Associates, said in a release. “If approved by the FDA, a once-daily, fixed-dose combination of atazanavir sulfate and cobicistat would offer patients living with HIV-1 another treatment option.”

BMS, which manufactures Reyataz, has entered into a licensing agreement with Gilead Sciences, which makes cobicistat, to develop and market the combination tablet.

To read the release, click here.

Search: Bristol-Myers Squibb, BMS, Reyataz, cobicistat, atazanavir, ritonavir, boosting agent, U.S. Food and Drug Administration, FDA, Norvir, new drug application, Brian Daniels, Calvin J. Cohen.


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 POZ team reviews all comments before they are posted. Please do not include either ":" or "@" 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]


Join POZ Facebook Twitter Google+ MySpace YouTube Tumblr Flickr
Quick Links
Current Issue

HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
HIV 101
Disclosing Your Status
Starting Treatment
Help Paying for Meds
Search for the Cure
POZ Stories
POZ Opinion
POZ Exclusives
Read the Blogs
Visit the Forums
Job Listings
Events Calendar


    dversescott
    Baltimore
    Maryland


    newlife202
    JOLIET
    Illinois


    ernienyc
    Bronx
    New York


    blaze11212
    brooklyn
    New York
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Survey
Pop Watch

more surveys
Contact Us
We welcome your comments!
[ about Smart + Strong | about POZ | POZ advisory board | partner links | advertising policy | advertise/contact us | site map]
© 2014 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.