BMS Withdraws Asunaprevir NDA

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approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b in the U.S. and has withdrawn its NDA for asunaprevir.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 Japan, BMS received regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese HCV patients the first all-oral, interferon- and ribavirin-free treatment regimen. The dual regimen was developed to meet the distinct need of this Japanese patient population.
 
In the EU, daclatasvir was recently approved for use in combination with other products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. The company also believes that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.
 
BMS plans to submit additional data for daclatasvir to the FDA from the ongoing clinical program focused on difficult-to-treat patients, including patients with HCV genotype 3, patients who are pre- and post-liver transplant, and patients co-infected with HIV.