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BMS withdraws asunaprevir NDA

October 8, 2014 1:42 AM UTC

One day prior to releasing data on regimens including its daclatasvir to treat HCV, Bristol-Myers Squibb Co. (NYSE:BMY) said it has withdrawn its NDA for asunaprevir and will no longer pursue FDA approval of a dual daclatasvir/asunaprevir regimen to treat HCV genotype 1b.

BMS attributed its decision to the "evolving HCV treatment landscape in the U.S.," which is changing since the launch of Sovaldi sofosbuvir, a nucleotide analog HCV NS5B polymerase inhibitor, by Gilead Sciences Inc. (NASDAQ:GILD) in December 2013. ...