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29837 tn?1414534648

FDA Response To Vertex Application

Today, I spoke to my contact at the FDA, who said "Fast Track" does not mean the new drug application will be reviewed right away. This is disturbing. It means that they will review it in order of efficacy reports of the clinical trials held by Vertex, by a Blue Ribbon Panel (medical experts). Vertex stated in their press release that Telaprevir should be available to the public on  May 23rd. This does not make that date carved in stone. Keep in mind the final decision has to be made by the Blue Ribbon Panel review of the drug, not by Vertex.

The Blue Ribbon Panel are medical experts who will decide if this product will help in eliminating a serious problem (Hepatitis C), from information received all the way from the beginning of the clinical trials, and of the totality of information received. They then will have to make a decision within six months, unless they require “more information”, even though it has been applied as a “Fast Track”. Let’s keep our fingers crossed for the May 23rd date...

Magnum
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Avatar universal
>Some drugs take decades.
and hopefully this is because the testing and evaluation are genuinely difficult : the benefit is marginal or the risks substantial or the volume of data inadequate. None of those apply here. Every single trial has demonstrated statistically significant improvement of treatment over control, serious complications were none to minimal, discontinuation due to tx-related sx marginally higher than soc, and the volume of patient data abundant. Seems that someone in Rockville who has been following these trials since Phase I could size up the new phase III data in a couple of weeks, leaving plenty of time for golf.

The careful evaluation *is* essential. The road to tela and boce is littered with about a half-dozen wrecks (biln-2061, r1626, etc. ) that had to be pulled. But the pace seems glacial.  Maybe  this is indeed as fast as can it  possibly  go - but that was not the case for HIV HAART therapy  and Act-Up's shutting down the FDA  played a part in conveying urgency.

I'd bet there are no HCV patients involved in the current approval timetable/deliberations.
Helpful - 0
Avatar universal
Vertex commented at an NVHR meeting last week that the FDA is required to come back with a yes or no answer to approval by 5/23.
Helpful - 0
92903 tn?1309904711
"So a mere  eight years for clinical testing and evaluation?"

Some drugs take decades.

The logic here has the beauty and clarity of a flawless diamond. Which, I shouldn't add, could take millions of years to form.
Helpful - 0
Avatar universal
If you would like a heads-up on the fda process, go to fda's home page and search (in the upper right corner) for "Priority Review Process". The first link takes you to a page on fda's site that thoroughly explains "Fast Track", "Priority Review", and "Accelerated Approval". Priority review sets a *target* of 6 months. Their median success in meeting this target is close to, but usually a little longer than 6 months. But that's median. If you scroll down to "Summary" you will see that "Pegasys" was approved for marketing in only 4 months. One can only hope.

By the way, lets hope the, uh, folks in Washington don't force a govt. shutdown on March 4th. The FDA's approval process will stop dead in the water.
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190885 tn?1333025891
as our bureaucracy eats itself alive...i don't get what your up to? ...who cares if it takes or took our bureaucrats decades to make a move on other drugs? aren't we all looking for change ..like maybe doing things faster and better then in the past?..............billy
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148588 tn?1465778809
Probably plenty of cancer patients ticked off to have even one 'bureaucrat' pulled off of reviewing *their* DAAs and slowing down those approvals for something like HCV.
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Avatar universal
"So a mere  eight years for clinical testing and evaluation?"

Some drugs take decades.
Helpful - 0
190885 tn?1333025891
this is such a drag...but i still think it will be available this summer...thanks for the info magnum
Helpful - 0
Avatar universal
yeah, we should mingle and bleat gently. Anything else is not in the nature of hcv patients. Never mind that in 2003, Chao Lin of Vertex, probably the main developer behind tela, published a review in which, from a chemical perspective, tela (then vx950) was already history:

(See the Clinical Development section of "Chapter 6: HCV NS3-4A Serine Protease" in
http://www.ncbi.nlm.nih.gov/books/NBK1623/

So a mere  eight years for clinical testing and evaluation?  Complete phase III data has now been available for months and still  peer review of the results is getting squeezed for time. Truly, the breakneck speed is  dizzying. They'll have to slow down and rest before  the next round of drugs.
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Avatar universal
^^^Edit to add:  Industry and conservatives never miss a chance to diss the government for costing business money, taxes are too high, etc.  User fees paid by pharma to the treasury in order to facilitate drug (and device) reviews are popular.  They wouldn't give them up for anything, because it gets their products to market.  
Helpful - 0
Avatar universal
You should familiarize yourself with how a drug is trialed and then the data reviewed, instead of raising the "bureaucratic" flag over this.  

Years ago, the average review time for a new drug was 30 months.  Not because the reviewers are out playing golf, but because the application and data amount to hundreds of thousands of pages, and there is peer review involved.  

Under PDUFA, the industry pays fees for the agency to hire additional reviewers.  That's why you can now get an advisory panel review and an "intent to approve" letter in 6 months instead of 30.  

Complain all you like, it's still a lot better than it used to be.  
Helpful - 0
92903 tn?1309904711
This level of bureaucratic quagmire is ludicrous. The data has been accumulating for years, There's no reasonable reason that partial reviews could not have been undertaken so the FDA panel was ready to roll once formal submission was made. 6 mos to make a decision? What's that about - diffuculty scheduling around golf vacations? Jesus!!!  
Helpful - 0
446474 tn?1446347682
Fingers and toes crossed...

SUMMARY: Vertex Pharmaceuticals announced last week that the U.S. Food and Drug Administration (FDA) and Health Canada have agreed to priority review of telaprevir, the company's experimental hepatitis C virus (HCV) protease inhibitor currently in Phase 3 clinical trials. FDA's 6-month accelerated review could result in an approval decision by late May. Along with Merck's boceprevir, also under priority review, these first direct-acting oral agents are expected to usher in a new paradigm for chronic hepatitis C treatment.

From Vertex's website:

"U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C"

-Six-month review date of May 23, 2011 set by FDA-

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- "Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.

(PDUFA dates are deadlines for the FDA to approve new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review then 6 months is allotted. These times begin from the date a NDA is submitted).

Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.

In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.

"Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."

Data to Support the Telaprevir Submissions

The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months — half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission".

hectorsf
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96938 tn?1189799858
Seems like it should be a Yellow Ribbon Panel.
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