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Telaprevir nearly ready for FDA filing

Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"

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Wednesday, August 11, 2010
Posted by New HCV Drugs
FILE UNDER TELAPREVIR, VERTEX
From Our Friend At Sherlingsplowed
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Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"
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More very encouraging Vertex
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"Next Gen" Hep C candidate (telaprevir) study data -- this time from Vertex's ILLUMINATE trial -- is being splashed across the wires, early this morning:

. . . .Vertex announced. . . new clinical data Tuesday demonstrating that nearly all hepatitis C patients who respond early and robustly to treatment with the company's experimental drug telaprevir achieve a cure after six months -- reducing the conventional treatment time for the disease in half. . . . These data are particularly important to Vertex because it helps differentiate telaprevir from its main competition at this point for hepatitis C patients, namely Merck's experimental drug boceprevir. Treatment with boceprevir yielded hepatitis C cure rates of 63% and 66% but treatment duration ranged from 28 weeks to 48 weeks, according to results of a phase III study announced by Merck on August 4, 2010. . . .
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Stay-tuned, but this would suggest that -- as I've long-held -- Vertex will file first; be first approved and enjoy an efficacy advantage over legacy Schering-Plough/New Merck's boceprevir.
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6 Responses
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Avatar universal
How soon till we may see this out do you think? Jan
Helpful - 0
Avatar universal
Can't say for sure, I can guess. Most stories say second half of 2011.  I'm hoping by next June, read June somewhere.  The feds are not the best to rely upon for prompt action.
Helpful - 0
1253246 tn?1332073310
Yeah!!! Sounda good 2 me!!!If its approved and on market by June I will be out of school for 10 weeks.Perfect timing for me.We will probably be treating together!!!Cross your fingers(and toes) cindy
Helpful - 0
Avatar universal
There will be alot of treatment at the sametime.
Judy
Helpful - 0
Avatar universal
This is such exciting news!  When I read about people on this forum who did not achieve SVR through SOC, hearing this news just makes my heart swell.  

You are right about the Feds -- they do have a tendency to lag, but this med will definitely be fast-tracked.  There are just too many people who need it.  

Debbie
Helpful - 0
179856 tn?1333547362
Lets hope that it happens finally at last!
Helpful - 0
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