Bristol-Myers Squibb Applies To The FDA For New Hepatitis C Drugs

A Bristol-Myers Squibb announcement indicates that the company has put in two new drug applications (NDAs) to the U.S. Food and Drug Administration (FDA) for two new products it is testing to be used in combination to treat hepatitis C (HCV). The data to support the applications for these products, daclatasvir (DCV) and asunaprevir (ASV) — an NS5A replication complex inhibitor and NS3 protease inhibitor respectively — is specific to treatment for genotype 1b hepatitis C (HCV). The company is also seeking approval for DCV use for multiple hepatitis c genotypes when used in combination with other pharmaceutical products. These submissions are under review for acceptance for filing.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to U.S. HCV patients, many of whom continue to have high unmet medical needs. We are excited to have achieved this milestone and, looking forward, will continue to innovate and invest in daclatasvir in a range of patient types and regimens,” noted Bristol-Myers Squibb’s Brian Daniels, SVP of Global Development and Medical Affairs, Research, and Development.

Recently, the FDA granted the combination treatment of DCV + ASV, also called DCV Dual Regimen, “Breakthrough Therapy Designation.” The company has another treatment consisting of daclatasvir/asunaprevir/BMS-791325 with the same designation under investigation and expects to submit an application to the FDA for this treatment regimen in early 2015.

Japan and Europe have accepted applications for DCV treatment combinations and these are under expedited review by their respective regulatory agencies.

Hepatitis C is a viral infection of the liver contracted through direct exposure to infected blood or blood products. Estimates indicate that about 170 million are infected with hepatitis C globally, and approximately 2.7–3.9 million individuals in the United States suffer from chronic hepatitis C infection.  An estimated 20 percent of those with chronic infection develop cirrhosis; and as many as 25 percent of those with cirrhosis will get cancer of the liver.