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New Drug Application for Asunaprevir Withdrawn in US
In October, Bristol-Myers Squibb announced the withdrawal of a new drug application for asunaprevir. The company will no longer pursue FDA approval for its dual regimen of daclatasvir and asunaprevir for the treatment of patients with hepatitis C virus genotype 1b infection.
The reason cited for withdrawal was the “rapidly evolving HCV treatment landscape,” according to a company press release.
However, Bristol-Myers Squibb will continue to seek FDA approval of daclatasvir, an NS5A complex inhibitor that is currently under investigation worldwide in multiple treatment regimens for patients with HCV.
According to the release, the company plans to submit additional data on daclatasvir to the FDA, based on an ongoing clinical trial of difficult-to-treat participants with HCV, including those with genotype 3 infection, pre- and post-liver transplant patients, and those coinfected with HIV.
The dual regimen of asunaprevir and daclatasvir was approved in Japan in July, making it the first all-oral, interferon- and ribavirin-free treatment regimen. According to the company, 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. Data presented at the International Liver Congress 2014 indicated that the dual regimen was well tolerated and produced high sustained virologic response in patients with HCV genotype 1b infection, according to the release.