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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.
'
0
Wednesday, August 11, 2010
Posted by New HCV Drugs
FILE UNDER TELAPREVIR, VERTEX
From Our Friend At Sherlingsplowed
h
Telaprevir Nearly Ready For FDA NDA Filing -- Likely To Be "Fast-Tracked"
'
More very encouraging Vertex
'
"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. . . .
'
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.
'
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
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
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
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.
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