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Author Topic: Isentress is coming!!!! FDA finds it "Safe and Efficient"...  (Read 1471 times)

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Offline J220

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  • Posts: 587
Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« on: September 01, 2007, 11:30:34 PM »
The FDA has posted a paper on their website ( http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4314b1-01-Merck.pdf ) - it's a large PDF file, be advised- in which they conclude that Merck's Isentress (raltegravir):

"All doses used throughout the Phase II and Phase III studies have demonstrated potent efficacy and a favorable safety profile."

This is the key official finding we were waiting for. Now the next step is an official vote within the FDA in October, and if the 'ayes' have it - which seems highly likely- the drug will be approved. This is absolutly great news for everyone, but mainly those who have developed resistance. And even for those of us still on our front line therapies, it is yet more breathing room, knowing that this drug is there should we need it.

For those not familiar with Isentress, here are a few key notes, provided in the FDA's paper:

Fulfills an unmet medical need for a novel anti-retroviral therapy (ART) for patients with multi-drug resistant HIV.

Has significant antiviral activity against multi-drug resistant HIV-1.

Has a broad spectrum of activity and no cross-resistance to currently licensed ARTs.

Has demonstrated rapid, potent, and superior antiretroviral efficacy compared to placebo plus OBT in treatment experienced patients in a comprehensive clinical development program.

Is both efficacious and generally well tolerated in a diverse group of patients representing different genders, races, geographic regions, viral sub-types, and hepatitis B and/or C virus co-infection status.

Has a favorable risk/benefit profile.


There is more info on Merck's website, I am sure, (but I am too lazy to get the exact link right now). But all in all, this is great news. Cheers everybody, J.
« Last Edit: September 01, 2007, 11:32:36 PM by J220 »
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline thunter34

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  • Posts: 7,314
  • His name is Carl.
Re: Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« Reply #1 on: September 01, 2007, 11:58:27 PM »
Great news.  Thanks for posting.

Cheers back at ya, J!

AIDS isn't for sissies.

Offline powerpuff

  • Member
  • Posts: 138
Re: Isentress is coming!!!! FDA finds it "Safe and Efficient"...
« Reply #2 on: September 08, 2007, 06:39:38 PM »
good hopeful, hope side effects are minimal.

 


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