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DewDiligence

11/03/13 3:56 PM

#169250 RE: dewophile #169248

BMY submits Japanese NDA for Daclatasvir + Asunaprevir combination in genotype-1b HCV:

http://news.bms.com/press-release/bms-submits-first-all-oral-interferon-free-and-ribavirin-free-treatment-regimen-regula&t=635189834629733930

BMY will presumably be first to market with an all-oral regimen for GT1b in Japan, but ABBV/ENTA have a similar regimen (ABT-450 + ABT-267) in phase-3.

For GT1b global registration (i.e. excluding Japan), BMY is testing Daclatasvir + Asunaprevir ± ribavirin in a 200-patient phase-3 trial expected to finish in Oct 2014 (http://clinicaltrials.gov/ct2/show/NCT01973049 ).