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Timeline for Telaprevir FDA approval decision
Vertex Pharmaceuticals(VRTX_)
Drug/indication: Telaprevir for Hepatitis C
Approval decision date: May 23, 2011 (estimated, based on Vertex's filing for approval on Nov. 23, 2010 and assuming six-month FDA review.)
You wrote back in January-->>>---"Seems to me that the IL28B is now a "standard" test if you're 1a"
Do you have perspective about whether Geno-1a with TT or CT or CC would get treatment priority if all other factors are the same?
If any one else knows then please adivse.
Reckon I am getting a little focus on what to expect if May 23rd those in fact bring approval. Not getting any younger or better as weeks, months or years pass by.
Thanks
Do you have perspective about whether Geno-1a with TT or CT or CC would get treatment priority if all other factors are the same?
If any one else knows then please adivse.
Reckon I am getting a little focus on what to expect if May 23rd those in fact bring approval. Not getting any younger or better as weeks, months or years pass by.
Thanks
The FDA will decide if they approve Telaprevir on May 23. If they approve it you will be able to get it prescribed by your doctor. It won't be long now, just a couple of months and we will know more.
hi every one if any body can tell me that telaprevir is avaialble in the market and how do i get it. i will really appreciate if any body will send me the complete details about it.
I, too, am wondering. The sooner the better because of current strong insurance policy.
My guess is that the second it is approved it will be out the door and in your veins. Have you ever seen big biz drag their feet when there was money to be had and no government hold backs?
My guess is that the second it is approved it will be out the door and in your veins. Have you ever seen big biz drag their feet when there was money to be had and no government hold backs?
hey, new here. not to hep c, just this sight. i'm back on board. 7 yrs. ago i did the iterferon treatment. first the 3x a week thing, and when that didn't work, went to the every day for a year thing. took about 4 months of every day befor i gave up. horrible side effects. i pretty much know what to expect from the telaprevir treatment. my doc says i'm on the list for june though. now i'm starting to wounder if they'll be an insurance hangup. i guess i'll be calling up today.well,i like hearing the stories around here, we're all in this together.......
l live in Australia, my partner is also Hep c, his doctor told him today that it would be 18 months before telaprevir was availbable here. l find this hard to believe. l am currently waiting to be assessed for participation in a 3 drug combo trial, really hoping that l get axccepted now, given the possible long wait otherwise.
Seems to me that the IL28B is now a "standard" test if you're 1a. So, let us know how this goes with your insurance carrier as it may be indicative of how readily they'll okay the Telaprevir when it comes out.
I will be making a visit to my dr on Thursday,along with a long list of questions-this being one of them.Im hoping after approval we can get them right away since Im off from work all summer.Hoping theres no lags !!!My dr told me back in October that Vertex was hiring thier people and wanted them to be ready.He has a friend who was hired on.He knew something then and maybe he knows more now-Will let you all know.By the way going for the IL28B test tomorrow-Praying but will accept what I get-cindy
I kinda figure they'll be a lag there. If the drug is actually approved in June, it may take several months for all the processes to kick in. Who knows.
I asked my hepatologist back in Aug. how likely it'd be for my insurance (BCBS) to cover the Telaprevir and he responded "they'll have to as it will be the new SOC BUT, we don't know how much pain and suffering they'll put you through first." I do know that my PCP pushed me to get into a trial when one of his fellow physician's was having trouble getting availability of a newly approved drug, that his young son needs, covered by insurance. This is anecdotal and only time will tell but, from what I've seen and experienced directly, the only ones coming out ahead these days are the insurance companies as they deny and linger over payments to the medical profession and approving needed coverage to the policy holder.
Wonder how long it will take to get everything in the pipeline - insurance co formulary up to date, treatment approval procedures in place, drug in stock, etc.
Anyone else have any personal experience?
Anyone else have any personal experience?
By May the Data from the vx-950 and vx-222 plus SOC will be availible. I talked with someone who is doing the trial and they can't say anything but I did get the nod and wink so this should be an exciting year, Who knows, if this is as good as I hope ( 12 week treatment ) then about the time FDA approves vx-950 the phase 3 trials shoud get under way,
I wonder if availability is later in Canada because the medical system there being socialized. I have heard some medical care can take longer to get in Canada then the US. But at least it's available to everyone, unlike here in US.
My nurse said probably Fall 2011 for Canada availability of new drug when I was starting treatment.
Vertex has other companies to market the drug outside of the US. If past experience with drug approvals is of value, it seems to me the FDA is the toughest one to get drug approval through. So many drugs are available outside the US not approved yet here. In this case it's a US drug company Vertex that has developed the medication, not a European drug company, which is often the developer of many new meds. I would guess once Telaprevir is approved here it will be available everywhere shortly thereafter, but I have never followed a new meds arrival on the public scene before so I am only guessing.
A question from a hep c'er in Australia, was just wondering, does approval of a drug in the USA mean that it is also approved in Australia? If telaprevir is available as of May 2011 in USA, what is the proceedure for world wide usage?...
Everything I hear from Kaiser says June.
Are you planning on treating again?
My doctors are still against it for now, just can't seem to get the copd under control, if I can't oxygen is the the next step. It's like one step forward 5 steps back.
But hopefully with a little miracle we can start in june.
Good luck
donna
Are you planning on treating again?
My doctors are still against it for now, just can't seem to get the copd under control, if I can't oxygen is the the next step. It's like one step forward 5 steps back.
But hopefully with a little miracle we can start in june.
Good luck
donna
I've never followed a drug being approved by FDA until Telaprevir. I know Vertex has hired sales reps in anticipation of it being approved. FDA has 45 days starting 11/23 to decide on fast track approval 6mo or reg approval 10 months. Not sure if that's business days or calendar days. But should be coming up. The study results as so good it's hard to imagine delaying approval to market as that one guy said. I will be sure to ask my doc about how fast it will be available to order once approved. Perhaps someone here can ask their doc, since I don't see mine until March. I really don't think the FDA can let a drug company know if it's going to approve a drug beforehand. Too much money making insider information issues at stake. But I'm sure Vertex is lobbying hard after 15 yrs of testing and development, they deserve payback and we deserve the treatment.
I have heard for sometime June 2011 it would be available so the story makes some sense now regarding timeline.
I have heard for sometime June 2011 it would be available so the story makes some sense now regarding timeline.
I have to believe Vertex knows if their drug is going to get approved. They are probably already producing it to have it ready to ship as soon as approved. The faster they can get this out and be the "only game in town" before Boceprevir hits the market, the more $$ they can rake in.
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From the 11/23/10 vertex press release on filing the application
"The submission includes a request for Priority Review, which would reduce the FDA’s review time from 10 months to six months. The FDA grants Priority Review status for several reasons, including if the medicine is considered a major advance in treatment."
From the FDA website
"FDA determines within 45 days of the drug company’s request whether a Priority or Standard Review designation will be assigned"
" Standard Review is applied to a drug that offers at most, only minor improvement over existing marketed therapies. The 2002 amendments to PDUFA set a goal that a Standard Review of a new drug application be accomplished within a ten-month time frame.
A Priority Review designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. ****A Priority Review means that the time it takes FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months."