Treatment News : FDA Grants Priority Review Designation for ViiV’s Dolutegravir

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

Back to home » Treatment News » February 2013

Most Popular Links
Most Popular Lessons

The HIV Life Cycle


Herpes Simplex Virus

Syphilis & Neurosyphilis

Treatments for Opportunistic Infections (OIs)

What is AIDS & HIV?

Hepatitis & HIV

20 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


February 19, 2013

FDA Grants Priority Review Designation for ViiV’s Dolutegravir

The U.S. Food and Drug Administration (FDA) has granted ViiV Healthcare priority review designation for the company’s new integrase inhibitor dolutegravir. Representing a joint effort between GlaxoSmithKline, Pfizer and Shionogi, ViiV submitted dolutegravir to the FDA for use in combination with other antiretrovirals (ARV) in adults and adolescents. The priority review indicates that, if dolutegravir is approved, the drug has to potential to either provide significantly improved therapy as compared with other ARVs or to provide a treatment where there is no adequate existing therapy.

ViiV submitted its application for dolutegravir to the FDA in December 2012 on the basis of results from four Phase III clinical trials. These trials included a total of 2,553 HIV-positive patients from a wide array of treatment backgrounds: from treatment-naive to salvage, in which all other regimens have been exhausted.

The FDA is scheduled to issue a decision on the drug’s approval by August 17.

To read the Yahoo News report, click here

To read the ViiV release, click here.

Search: HIV, antiretroviral, dolutegravir, FDA, priority review designation, ViiV Healthcare, GlaxoSmithKline, Pfizer, Shionogi

Scroll down to comment on this story.


(will display; 2-50 characters)


(will NOT display)


(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]

Facebook Twitter Google+ MySpace YouTube Tumblr Flickr Instagram
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
POZ on Twitter

Ask POZ Pharmacist

Talk to Us
Did you participate in an event for National Black HIV/AIDS Awareness Day 2016?


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]
© 2016 Smart + Strong. All Rights Reserved. Terms of use and Your privacy.
Smart + Strong® is a registered trademark of CDM Publishing, LLC.