Given the rapidly evolving hepatitis C treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue U.S. Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor.
The company will continue to pursue FDA approval of daclatasvir…which is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.
Not a big surprise insofar as the Daclatasvir/Asunaprevir regimen was strictly second-rate, as you noted in #msg-100193945.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”
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