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

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

From Our Friend At Sherlingsplowed

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

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.

http://Hepatitis Cnewdrugs.blogspot.com/2010/08/telaprevir-nearly-ready-for-fda-nda.html