Breaking News, Trials & Filings

BMS Withdraws Asunaprevir NDA

Will continue to pursue FDA approval of daclatasvir

Author Image

By: Kristin Brooks

Managing Editor, Contract Pharma

Amidst the growing development of hepatitis C (HCV) treatments, Bristol-Myers Squibb has decided not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b in the U.S. and has withdrawn its NDA for asunaprevir. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which is currently being investigated in multiple treatment regimens for HCV patients with high unmet need.   In...

Continue reading this story and get 24/7 access to Contract Pharma for FREE


Already a subscriber? Sign in

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters