Bristol-Myers Squibb Withdraws FDA Application for Hepatitis C Treatment

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The drugmaker will no longer pursue FDA approval of its dual daclatasvir and asunaprevir treatment for patients with hepatitis C virus genotype 1b.

Bristol-Myers Squibb will no longer pursue FDA approval of its dual daclatasvir and asunaprevir treatment for patients with hepatitis C virus (HCV) genotype 1b, the drugmaker announced today.

Consequently, the company has withdrawn its new drug application for asunaprevir, an NS3/4A protease inhibitor, “given the rapidly evolving HCV treatment landscape in the United States,” it said in a statement.

However, Bristol-Myers Squibb will continue to seek FDA approval of daclatasvir, a pan-genotypic NS5A complex inhibitor, for difficult-to-treat HCV patients, including those with HCV genotype 3, those who are pre- and post-liver transplant, and those who are co-infected with HIV.

“Bristol-Myers Squibb’s HCV strategy has always been to focus on the unique unmet medical need of each local market. The dual regimen was developed to meet the distinct need of the Japanese patient population, and we believe 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,” the company said. “Similarly, we believe that daclatasvir-based regimens have the potential to fill continued unmet medical need in the United States and elsewhere in the world.”

The drugmaker plans to submit data from its ongoing clinical trial program for daclatasvir to the FDA, and it will present new data from several daclatasvir-based regimens at the annual meeting of the American Association for the Study of Liver Diseases next month.

“We look forward to bringing daclatasvir to patients in the United States 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,” Bristol-Myers Squibb said.

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