Aa
Aa
A
A
A
Close
29837 tn?1414534648

Vertex's Response To "Compassionate Use"

Below, is the response I received today from Vertex. This means no "Compassionate Use", but... it also means they are applying for a license soon. So this is good news, bad news...

Magnum

Thank you for your inquiry regarding telaprevir (VX-950), an investigational drug candidate that
specifically targets hepatitis C virus (HCV).

You requested information regarding an expanded access/compassionate use program for
telaprevir.

While we are continuing to assess, at this time there is neither a compassionate use nor an
expanded access program available for telaprevir.

Our intention is to file with the FDA for approval in the second half of 2010. At this time, there is
no specific date identified when telaprevir could be available by prescription. All efforts are being
taken to complete the required evaluations to allow telaprevir to be made available by
prescription.

We appreciate your interest in Vertex Pharmaceuticals Incorporated. Please view our website
(www.vrtx.com) for the status of all our investigational compounds and clinical studies or contact
Medical Information at 1-877-MDI-VRTX (1-877-634-8789) should you have any additional
questions.

Sincerely,

Alan True, Pharm.D.

Vertex Pharmaceuticals Incorporated
13 Responses
Sort by: Helpful Oldest Newest
476246 tn?1418870914
That sukks, I'm sorry they turned you down!

Hugs, Marcia
Helpful - 0
179856 tn?1333547362
FRIJOLE!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

You just made my day chickie, seeing your name really put a smile on my face!  :)
Helpful - 0
223152 tn?1346978371
I am glad you are sharing your interaction with Vertex.  It is unfortunate that they are not willing to go with compassionate use.  I don't understand what they have to lose, except that they may not be in the position right now to manufacture and market.  

If I recall, reading from the investor news, Vertex, unlike other R&D companies wants to retain Telaprevir and market it itself.  Most R&D companies would be looking for a buyer fairly soon.   So I wonder if that factors into their decision not to help relapsers right now.  

Hopefully you ( and the rest of us relapsers) will not have too long to wait.
frijole

Helpful - 0
Avatar universal
Magnum,
I am sorry to hear that your request was denied. At least you tried. Thank you for sharing this with all of us.

All,
I think expanded access is possible. I also think individual patient INDs are possible in spite of what has happened to Magnum. If we are not satisfied with how this plays out in the coming months, then we can submit another 200 individual patient IND applications.

PS
Vertex may prefer to complete the REALIZE clinical trial before releasing telaprevir. REALIZE has about 650 patients – all non-responders. One arm adds an IFN/RBV lead-in phase. Two telaprevir arms include 48 months of INF/RBV, because in PROVE3 this duration got better results. Results from REALIZE will help guide our physicians on how best to administer these drugs. There will be more data on drug resistance and what real risks they might pose. Data should be available in the July-September time period. I know it is hard to wait. I have been waiting for 20 years.
Helpful - 0
897070 tn?1320652629
Pretty angry to hear this news, why expanded access for HIV and not HEP C ? My consultant has been inferring that EA was quite possible. Guess he was wrong.
Helpful - 0
Avatar universal
one of the fastest FDA approvals ever was for peg-interferon - 42 days.  of course that was just a new formulation for an approved compound for HCV.  Other fast approvals occurred with HIV drugs in the 90's.  apparently unmet need is a motivator for the FDA.  I think it could go pretty quick if vertex has its act together.  certainly by the end of 2011 if  vertex gets all the necessary info to the FDA by the end of this year.  
Helpful - 0
Avatar universal
It makes me so angry that these sh!ts are sitting on a drug which is needed desperately to save lives.  I think they are using people like you to put pressure on the FDA to get faster approval.

While I feel like cursing them for their ethics / morality, I am going to restrain myself because at the end of the day this drug will improve the cure rate for hepC sufferers and that is a good thing.  They never claimed to be Mother Teresa.

Thanks for getting this information for us.  Hang in there,
dointime    
Helpful - 0
Avatar universal
I'm sorry to hear this response, Maybe you should try Merck also.
Helpful - 0
317787 tn?1473358451
As someone who is waiting for this tx to be approved I appreciate you posting, I relapsed with Roch 1626, responded by 8th week so I hope this new tx will help me.  I am starting to have new extra hepatic symptoms and sure could use the help.
My liver doc said that it would hopefully be out in 2011 and that people might not have to treat as long, could even be 24 weeks, his words.  I, myself, after the hell I went through on the last tx, would treat as long as possible to kill this virus and the cryoglobulins  I want to get better, like I was before treatment.  I felt fine before tx, it has been a year and 5 months since last tx and I am just starting to feel normal.  24 weeks sound nice but as a 1a I know I need to treat longer.
Thank you again
D
Helpful - 0
Avatar universal
"As for drug companies they get alot of funding from goverment directly and indirectly so the comment about cure yourself is inappropriate. Fingers Crossed!!


Its the way around my friend,drug compaines fund govts
Helpful - 0
Avatar universal
Does anybody know how long it takes to get a drug approved by the FDA even if they are trying to fast track?
Helpful - 0
179856 tn?1333547362
I'm sorry Mag it was looking promising for a little while there i thought.  One of them will break soon and you will get it - just try to hang on, god it's got to be so hard on you but if anybody can do it I know it's you.

deb
Helpful - 0
Avatar universal
I think the problem is they made money on the rumor and that is good enough. Their data seems to good not to allow this the only thing it can be is greed. Same thing for everthing else. I hope my liver lasts untill they get this out. I relasped after  72 week treatment and no detectable virus at end(below 5IU). Maybe it does not work when you have late stage
liver disease and they want to keep it secret. As for drug companies they get alot of funding from goverment directly and indirectly so the comment about cure yourself is inappropriate. Fingers Crossed!!
Helpful - 0
Have an Answer?

You are reading content posted in the Hepatitis C Community

Top Hepatitis Answerers
317787 tn?1473358451
DC
683231 tn?1467323017
Auburn, WA
Learn About Top Answerers
Didn't find the answer you were looking for?
Ask a question
Answer a few simple questions about your Hep C treatment journey.

Those who qualify may receive up to $100 for their time.
Explore More In Our Hep C Learning Center
image description
Learn about this treatable virus.
image description
Getting tested for this viral infection.
image description
3 key steps to getting on treatment.
image description
4 steps to getting on therapy.
image description
What you need to know about Hep C drugs.
image description
How the drugs might affect you.
image description
These tips may up your chances of a cure.
Popular Resources
A list of national and international resources and hotlines to help connect you to needed health and medical services.
Herpes sores blister, then burst, scab and heal.
Herpes spreads by oral, vaginal and anal sex.
STIs are the most common cause of genital sores.
Condoms are the most effective way to prevent HIV and STDs.
PrEP is used by people with high risk to prevent HIV infection.