Bristol-Myers Squibb withdraws asunaprevir from FDA approval

Bristol-Myers Squibb announced it has withdrawn a new drug application for asunaprevir and is no longer pursuing FDA approval for a dual regimen of daclatasvir and asunaprevir for the treatment of hepatitis C virus infection genotype 1b.

The approval of asunaprevir, a NS3/4A protease inhibitor, will no longer be pursued in the US due to the “rapidly evolving HCV treatment landscape,” according to a release from the manufacturer. However, the company is still seeking FDA approval of daclatasvir, an NS5A complex inhibitor that is currently being investigated globally in multiple treatment regimens for patients with HCV.

The company plans to submit additional data for daclatasvir to the FDA from an ongoing clinical trial centering on difficult-to-treat patients, including patients with HCV genotype 3, pre- and post-liver transplant and patients co-infected with HIV, according to the release.

“We look forward to bringing daclatasvir to patients in the US and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible,” the company said in the release.

The dual regimen was approved in Japan in July, making it the first all-oral, interferon- and ribavirin-free treatment regimen. The release indicated this served a unique need in the Japanese population. Daclatasvir was also recently approved by the European Union for use in combination with other products for the treatment of HCV genotypes 1, 2, 3 and 4, the release said.

Data presented at the 2014 International Liver Congress indicated that the dual regimen was well-tolerated and produced high SVR rates among patients with HCV genotype 1b. 

 

Bristol-Myers Squibb announced it has withdrawn a new drug application for asunaprevir and is no longer pursuing FDA approval for a dual regimen of daclatasvir and asunaprevir for the treatment of hepatitis C virus infection genotype 1b.

The approval of asunaprevir, a NS3/4A protease inhibitor, will no longer be pursued in the US due to the “rapidly evolving HCV treatment landscape,” according to a release from the manufacturer. However, the company is still seeking FDA approval of daclatasvir, an NS5A complex inhibitor that is currently being investigated globally in multiple treatment regimens for patients with HCV.

The company plans to submit additional data for daclatasvir to the FDA from an ongoing clinical trial centering on difficult-to-treat patients, including patients with HCV genotype 3, pre- and post-liver transplant and patients co-infected with HIV, according to the release.

“We look forward to bringing daclatasvir to patients in the US and will continue to work closely with the FDA to advance our regulatory application, with the aim of bringing the investigational product to market as quickly as possible,” the company said in the release.

The dual regimen was approved in Japan in July, making it the first all-oral, interferon- and ribavirin-free treatment regimen. The release indicated this served a unique need in the Japanese population. Daclatasvir was also recently approved by the European Union for use in combination with other products for the treatment of HCV genotypes 1, 2, 3 and 4, the release said.

Data presented at the 2014 International Liver Congress indicated that the dual regimen was well-tolerated and produced high SVR rates among patients with HCV genotype 1b.