BMS Withdraws NDA for Combination Hepatitis C DrugBy
Given the rapidly evolving hepatitis C (HCV) treatment landscape in the US, Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration (FDA) approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the United States and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.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 is currently being investigated globally in multiple treatment regimens for HCV patients.
“Bristol-Myers Squibb's HCV strategy has always been to focus on the unique unmet medical need of each local market,” said the company in a statement. “For example, in Japan we were pleased to receive 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.” In the European Union, 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.
Bristol-Myers Squibb says it plans to submit additional data for daclatasvir to the FDA from its 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.
Source: Bristol-Myers Squibb