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Author Topic: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen  (Read 721 times)

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Offline Mightysure

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https://www.gsk.com/en-gb/media/press-releases/viiv-healthcare-receives-complete-response-letter-from-us-fda-for-use-of-investigational-cabotegravir-and-rilpivirine-long-acting-regimen-in-the-treatment-of-hiv/

https://www.poz.com/article/fda-declines-approval-viivs-injectable-hiv-regimen-cabenuva





In a shocking move, the US Federal Drug Administration declined to approve what would have been the first HIV treatment regimen that did not require daily dosing.

ViiV received a Complete Response Letter  (CRL) declining to approve long acting injectable Cabotegravir and Ripilvirine over concerns regarding the Chemistry and Manufacturing Controls, not any safety  issues. The FDA nor ViiV elaborated on what the CMCs were or when ViiV can began to work on correcting the flaws in its application.

The FDA has never declined to approve an ARV regimen for HIV previously.

On a personal note, as someone in one of the research studies ehose data was used to apply for approval, this is a mixed blessing. This means that I will continue to get the medicine for free, but it means that I cannot join any of the cure studies going in because the ARV's I'm on are still investigational.

Offline ZachR

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  • Let's look at the stars again
Re: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen
« Reply #1 on: December 23, 2019, 05:50:16 pm »
It's sad that it's declined but it actually strengthens my trust in FDA and makes me believe that it works meticulously for the patients. This move shows that safety is prioritised over everything else.
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline Mightysure

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  • Posts: 425
Re: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen
« Reply #2 on: December 24, 2019, 01:09:16 pm »
Why does it improve your trust in the FDA? Their rejection had nothing to do with patient safety, but chemistey and manufacturing controls, which has nothing to do with how safe drugs are.

And the FDA approved every opioid on the market and keeps them there, so tell me how safety is paramount?

I think it's a protectionist thing. ViiV is a UK company coming for Gilead's, an American company, dominance in the market.

Offline ZachR

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  • Let's look at the stars again
Re: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen
« Reply #3 on: December 25, 2019, 02:09:18 pm »
  @Mightysure
Surely it does. Chemistry you say - isn't that what we're taking? Hencd, the purer and better managed the chemistry, the safer a drug.
Besides, if they don't care and want to kill us with drugs, then how come we're still around?

Sure we're not taking an aspirin a day, ours is a cocktail of potent drugs and as such toxicity is inevitable. Even aapirin can turn out very toxic, mind you. So, what's plan B for us then? I agree that even safer therapies can exist and with today's technology we're on the way to them, but meanwhile, we should be really thankful that we're spared a long and miserable death.
« Last Edit: December 25, 2019, 02:15:19 pm by ZachR »
25.10.19 VL 43
26.05.19  CD4+ 685 %26 VL 55
27.03.19  CD4+ 850 %31 VL 24
***Switched to Biktarvy due to side effects.
25.02.19  CD4+ 740 %30 VL 78
15.01.19  CD4+ 1600(might be wrong) %0.7 VL 54
05.11.18  CD4+ 720 VL 1,100
17.09.18  CD4+ 962 %25 VL 14,000,000 - Started first regimen on Triumeq
15.07.18 - diagnosed, CD4+ 490 %20
20.04.18 - infected

https://ibb.co/X74GV0X

Offline bocker3

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  • You gotta enjoy life......
Re: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen
« Reply #4 on: January 10, 2020, 06:46:43 am »
Why does it improve your trust in the FDA? Their rejection had nothing to do with patient safety, but chemistey and manufacturing controls, which has nothing to do with how safe drugs are.

Chemistry and manufacturing controls are indeed about patient safety!!!!  If there are any questionable controls, at any point in the manufacturing process, I would DEMAND that the FDA insist they fix it before staring to mass produce and distribute a drug.

Safety isn't simply about the studies -- it is also about the sourcing of material and production of the end product.

Mike
Atripla - Started 12/05
Reyataz/Norvir - Added 6/06
Labs - Pre-Meds
Sep05 T=350/25% VL98,559
Nov05 288/18%  47,564
Current Labs
May2015 969/28% <20

Offline Mightysure

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  • Posts: 425
Re: SHOCKER! FDA Declines to approve ViiV's monthly injectable ARV Regimen
« Reply #5 on: January 17, 2020, 02:43:20 pm »
Chemistry and manufacturing controls are indeed about patient safety!!!!  If there are any questionable controls, at any point in the manufacturing process, I would DEMAND that the FDA insist they fix it before staring to mass produce and distribute a drug.

Safety isn't simply about the studies -- it is also about the sourcing of material and production of the end product.

Mike


They're indirectly about patient safety. What the studies look for is the direct efficacy and safety of the drugs as they are. Chemistry and manufacturing controls are about quality assurance controls in place.
Here, the FDA never said there was an issue but they want to be sure that they have the controls in place. There has not be one single report of any negative effects from the drugs.

 


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