Bristol-Myers Squibb Withdraws NDA for Asunaprevir

Oct 07, 2014

Bristol-Myers Squibb said in a press release 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. The company has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.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 is currently being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

According to the release, the dual regimen was developed to meet the distinct need of the Japanese patient population, and the company 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 EU, daclatasvir was recently approved for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of HCV infection in adults.

Read the full release

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