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Phase III Results for Gilead Hep C Combo
tkim@idsociety.org
Posted: Wednesday, December 18, 2013 12:51 PM
Joined: 2/20/2013
Posts: 39


"Gilead unveiled a package of stellar late-stage cure rates for its closely watched hepatitis C combination of the newly approved "nuke" Sovaldi (sofosbuvir) and the NS5A inhibitor ledipasvir, putting it on a short path to the FDA with a new drug application planned for the first quarter of the coming year.

The success of the combo will speed up the likely near-term approval of a new therapy that can offer a large portion of genotype 1 hepatitis C patients a quick "cure" without interferon or ribavirin--the holy grail of this R&D field over the past few years. As a result, current standards of care are being swept away as Gilead leads a pack of avid rivals angling for a share of a megablockbuster market. Bristol-Myers Squibb and AbbVie are following closely behind Gilead in the race to the market."


To read more, please visit: Gilead races to the FDA with stellar PhIII results for its breakthrough hep C combo - FierceBiotech