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New and Improved Tenofovir Combination Submitted for FDA Approval

April 10, 2015

On April 7, Gilead submitted a new drug application to the U.S. Food and Drug Administration (FDA) seeking approval for emtricitabine/tenofovir alafenamide, at two fixed doses (200/10 mg and 200/25 mg), for the treatment of HIV in adults and children over 12.

The new drug is a reformulation of tenofovir/emtricitabine (Truvada), which includes the older version of tenofovir (Viread).

The newer tenofovir, tenofovir alafenamide (TAF), has been shown to be more potent at lower doses and gentler on the bones and kidneys.

This is the second application by Gilead for a drug containing TAF. In November 2014, the manufacturer submitted an application for a reformulation of elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), which included TAF.

Read the press release.

Warren Tong is the senior science editor for TheBody.com and TheBodyPRO.com.

Follow Warren on Twitter: @WarrenAtTheBody.


Copyright © 2015 Remedy Health Media, LLC. All rights reserved.




 

Reader Comments:

Comment by: Stanley Bodner (Nashville,TN) Tue., Apr. 14, 2015 at 5:08 pm UTC
Reformulated HIV drug combination tablets featuring replacement older tenofovir with its pro-drug "Taf" provides distinct clinical benefits and the newer reformulations incorporating "taf" will continue to secure Gilead's leadership and market share for prescribers for and patients challenged by HIV. Hopefully insurers and their pharmacy managers and ADAP formulary providers will follow suit with their support rather than prescription denials and inappropriate demands for prior authorizations or use of outdated treatment algorithms.
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Comment by: Don Freeberg (Oaxaca, Mexico) Tue., Apr. 14, 2015 at 4:56 pm UTC
Will this new formulation have an equally costly and prohibitive Price with a patent to keep it that way for a long time?
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Comment by: Jonathan Britton (Warwick, New York) Fri., Apr. 10, 2015 at 11:52 pm UTC
I can't help but think that, due to the encroaching time when Gilead's patent for Truvada (in its existing form) will expire and the door to far less expensive Generic versions hits the market, They are fabricating a superfluous change to Truvada in order to retain their current huge profit margins. This is based on what I already know of the Pharmaceutical Industry's galling record on both focusing primarily high profit products as well as gouging the market with huge price points on their drugs. I also suspect the industry is more engaged in treatment drugs while avoiding "Cures". The "Valley of Death" referred to within the research community refers to that long, hard fought battle waged to get new lab-based innovations into actual production; A battle too often lost to the pharmaceutical industry's in-house developments of ever more profit harvesting treatment modifications at the cost of the more exciting creations that get "shelved", or "deep-sixed". I have been a grateful recipient of life saving HIV medications since I was first diagnosed in 1987. The first concoctions were brutal in many ways, but they just barely got me to the mid-90's and the advent of HAART drug regimens, which brought me back from the brink. I feel reluctant to complain; Given the miracle of Lazarus I experienced, but I do so long for a cure to this disease and the end of all these medications. I know researchers around the world are working their butts off to find the answers; I fall short of believing the pharmaceutical companies are equally as dedicated to that end. Thank you.
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Comment by: Tyler (Canada) Fri., Apr. 10, 2015 at 2:59 pm UTC
God I hope this and the rest of the reformulations come soon.

Also like everyone else I have my fingers crossed they will release as a stand alone!
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