Bristol-Myers Squibb Company
(NYSE: BMY) today announced the submission of a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency seeking the world’s first interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C. The submission is based on results from a Phase III study demonstrating that the 24-week, all-oral, interferon-free and ribavirin-free regimen of daclatasvir (DCV) and asunaprevir (ASV) achieved an overall sustained virologic response 24 weeks after the end of treatment (SVR
) of 84.7% in Japanese patients with chronic hepatitis C (HCV) genotype 1b who were either interferon-ineligible/intolerant (87.4% SVR
) or non-responders (null and partial) to interferon-based therapies (80.5% SVR
These Phase III data will lead the Presidential Plenary at the Viral Hepatitis Session on November 5 during the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Washington D.C.
Globally, there are 170 million people who are infected with HCV. Of the 1.2 million people living with HCV in Japan, approximately 70 percent of these patients have genotype 1b, which has one of the lowest response rates to current treatments. Further, a significant number of patients with HCV in Japan are over the age of 65, leading to more disease-related complications and a decreased likelihood of tolerating interferon-based therapies, the standard for treating HCV.
“With our submission in Japan, we are pleased to be one step closer to bringing a potential new treatment option to the many people living with HCV in that country,” said
, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The all-oral regimen of DCV plus ASV in this study represents the potential for a significant advance in the treatment of HCV infection in Japan, particularly when considering that Japanese patients chronically infected with HCV are often older than in other countries and predominantly infected with genotype 1b, both factors which impact response to therapy.”
The regimen used in the Phase III study resulted in low rates of discontinuation (5%) due to adverse events (AEs). In addition, the rate of serious adverse events (SAEs) was low (5.9%) and varied among patients. Nasopharyngitis was the most common adverse event in the study (30.2%, 67/222).