Bristol Myers-Squibb Submits Investigational Hepatitis C Treatments for FDA Approval

Today, Bristol Myers-Squibb (BMS) announced it has filed for new drug applications (NDAs) with the FDA for investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor.

According to BMS, the data submitted in the NDAs “support the use of DCV+ASV in patients with genotype 1b hepatitis C.” The NDA for daclatasvir “also seeks approval for use of this compound in combination with other agents for multiple genotypes.”

The FDA recently granted the “investigational DCV Dual Regimen” (a combination of daclatasvir and asunaprevir) a “breakthrough therapy” designation. In 2013, the FDA also granted a “breakthrough therapy” designation to the all-oral “3DAA Regimen” (a triple-therapy combination of daclatasvir, asunaprevir, and the investigational compound BMS-791325).

Daclatasvir is currently being studied in the ongoing Phase III UNITY Program, where it is being investigated as part of an all-oral 3DAA Regimen (daclatasvir/asunaprevir/BMS-791325). Study populations include non-cirrhotic naïve, cirrhotic naïve and previously treated patients. The 3DAA Regimen is being studied as a fixed-dose-combination treatment with twice daily dosing.

Daclatasvir is also being investigated in combination with sofosbuvir in high unmet need patients, such as pre- and post-transplant patients, HIV/HCV co-infected patients, and patients with genotype 3, as part of the ongoing Phase III ALLY Program.

“These FDA submissions represent a major step towards offering daclatasvir-based regimens to US HCV patients, many of whom continue to have high unmet medical needs,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “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.”