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Bristol-Myers Squibb Files for FDA Approval of NS5A Drug Combination
tkim@idsociety.org
Posted: Thursday, April 10, 2014 1:50 PM
Joined: 2/20/2013
Posts: 40


"Three days after Bristol-Myers Squibb filed for FDA approval of the NS5A drug daclatasvir combined with asunaprevir, an NS3 protease inhibitor, the biotech company  has turned over some of the Phase III cards it will be playing for an approval in markets around the world.

Investigators say that the combo produced a sustained virological response of 90% in one group of patients in the genotype 1b pool, with other treatment-resistant populations registering in the low- to mid-80s. That may well prove good enough for an approval, but the results will also likely trigger considerable jockeying with rival all-oral combination therapies nearing the market."


To read more, please visit: http://www.fiercebiotech.com/story/bristol-myers-jockeys-promising-position-hep-c-drug-race/2014-04-10#ixzz2yVUhW9mo


 

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