Treatment News : The FDA Recommends Fast-Track Approval for TB Therapy in New Drug Class

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 » December 2012

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

December 13, 2012

The FDA Recommends Fast-Track Approval for TB Therapy in New Drug Class

The U.S. Food and Drug Administration’s (FDA) Anti-Infective Drugs Advisory Committee has recommended accelerated approval for bedaquiline, the first in a new class of tuberculosis (TB) therapy, aidsmap reports. The committee voted unanimously to support the new agent’s indication as a treatment for multidrug resistant (MDR) TB, and a majority voted that the safety findings of clinical trials supported this indication.

Internationally, and especially in sub-Saharan Africa, TB is a leading infectious killer, in particular among people with HIV. Many global efforts to fight HIV also focus on TB.

In a Phase II trial, researchers at the Faculty of Health Sciences at Stellenbosch University in Tygerberg, South Africa, conducted an eight-week randomized placebo-controlled study of 47 patients with MDR pulmonary tuberculosis and published their findings in Antimicrobial Agents and Chemotherapy. Twenty-three patients received bedaquiline, and 24 patients received a placebo. All patients also received a standard drug regimen for MDR-TB. After eight weeks of treatment, 48 percent of those on bedaquiline became sputum-negative, compared with only 9 percent of those on the placebo.

To read the aidsmap story, click here.

To read the study abstract, click here.

Search: FDA, HIV, tuberculosis, TB, therapy, fast-track approval, new drug class, aidsmap, bedaquiline, multidrug resistant, MDF, Stellenbosch University in Tygerberg, South Africa, pulmonary, trial.


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



Hide comments

Previous Comments:


         


[Go to top]


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

HIV 101
HIV Testing
Safer Sex
Find a Date
Newly Diagnosed
Disclosing Your Status
Starting Treatment
Search for the Cure
POZ Stories
POZ TV
Read the Blogs
Visit the Forums
Women
African American
Latino
Providers
Job Listings
Events Calendar


    acousticmat
    Oakland
    California


    RyGuy00
    New York
    New York


    Deelight4u
    BROOKLYN
    New York


    Fergie911
    Chicago
    Illinois
Click here to join POZ Personals!
Ask POZ Pharmacist

Talk to Us
Poll
Do you enjoy books with HIV-positive characters?
Yes
No

Survey
Mind Matters

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.