Telaprivir Not Applied For To FDA By Vertex

[Magnum]

Spoke to my contact at Vertex just now. Said the application for Telaprivir has NOT been submitted yet to the FDA. This is in response to a statement a member here made yesterday, in which she stated her doctor said it had been applied for to the FDA.

The comment my contact made is they are still in what he called "Phase 3 Development". So there it is... Wait, wait, wait, wait....

Magnum

[fretboard]

Hope you're doing well!  I would think that Vertex filed for an IND and is waiting for approval to actually file the NDA to market the drugs.  There's more than one part to the process and may be more than one part for the IND.  They would have to have everything taken care of otherwise they wouldn't have been told that they can conduct clinical trials.  It's a very detailed process.  good luck

http://www.fda.gov/downloads/Drugs/NewsEvents/UCM213444.pdf


http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm

[nygirl7]

Only time will tell now. After debating this same issue for years when when when will it be out - we should start a football pool type thing and see who wins.  

[Willy50]

Merck has started to start applying;

"We are excited by the results of these pivotal studies," said Dr. Peter S. Kim, Ph.D., president, Merck Research Laboratories. "In these studies, boceprevir substantially increased success rates compared to standard therapy, both for patients who received 48 weeks of treatment and for patients treated with the response-guided therapy approach, many of whom were able to be treated for 28 to 36 weeks," he added. "Based on these data, Merck has initiated the submission of a New Drug Application (NDA) for boceprevir to the U.S. Food and Drug Administration (FDA) on a rolling basis, and we expect to complete regulatory submissions in the U.S. and E.U. in 2010."
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A "rolling" basis means that as one phase 3 study wraps up they can apply for FDA approval on that basis.  It wouldn't be the complete blanket approval for all types of treatments. I think that Vertex is a bit further ahead and will apply a complete NDA but I confess, I don't know.  Each drug trial and treatment requires an approval from the FDA, to the best of my knowledge.  In that regard, the FDA so far as Vertex may approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well.  Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.  I admit that I'm not up on it but I think I'm in the ballpark, but don't quote me

As for Vertex..... they have maintained that they expect to apply for their NDA in late 2010 and there appears to be no reason to assume that won't happen.

It is yet another question; without regard to who files FIRST, I think the more important question is which drug will get approval first, what it will be priced at and what type of coverage insurance companies will initiate.  

First application doesn't mean first approval.  There will really be some choice, even though it may be confusing or difficult choice when these drugs roll out to the public.

Willy

[FlGuy]

I'm sure that when they apply there will be a "rash" of news.  Hope they can still afford the stamp for the envelope.

[Trinity4]

Tick....tick....tick