Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.
Bristol-Myers Squibb's HCV strategy always has been to focus on the unique unmet medical need of each local market. For example, in Japan the company received regulatory approval for the dual regimen of daclatasvir and asunaprevir in July, bringing Japanese patients with HCV the first all-oral, interferon- and ribavirin-free treatment regimen.
The dual regimen was developed to meet the distinct need of the Japanese patient population, and Bristol-Myers Squibb believes this treatment has the potential to play a major role in curing HCV patients in Japan, as well as in other markets where the HCV patient population is similar to Japan. In the E.U., daclatasvir recently was approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults. Similarly, the company believes that daclatasvir-based regimens have the potential to fill continued unmet medical need in the U.S. and elsewhere in the world.
The company plans to submit additional data for daclatasvir to the FDA from an ongoing clinical trial 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.