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November 4, 2013

Bristol-Myers Squibb files NDA in Japan for all-oral hepatitis C treatment

Bristol-Myers Squibb has filed a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency for the approval of an interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C (HCV).

By admin-demo

Bristol-Myers Squibb has filed a new drug application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency for approval of an interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C (HCV).

The NDA is based on results from a Phase III trial of Japanese patients who either could not tolerate interferon or those who were either interferon-ineligible/intolerant or non-responders to interferon-based therapies.

In the trial interferon-ineligible/intolerant (IN/I) patients (n=135) and interferon/ribavirin non-responder (NR) patients were given a combination of daclatasvir (DCV) 60mg once daily and the protease inhibitor asunaprevir (ASV) 100mg twice daily for 24 weeks.

"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."

Patients who had no detectable levels of the virus in their blood 24 weeks the end of the therapy were believed to be cured, a measure called SVR24, for sustained virologic response.

The company said that an overall SVR24 rate of 84.7% was achieved in Phase III 222-patient study of DCV and ASV in high unmet need genotype 1b patient population.

Bristol-Myers Squibb senior vice-president of global development and medical affairs, research and development Brian Daniels said: "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."

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In the open-label, parallel group Phase III trial, the DCV+ASV regimen had low rates of discontinuation (5%) due to adverse events, and low rates of serious adverse events (5.9%).

The combination regimen achieved 87.4% SVR24 rates in interferon-ineligible/intolerant patients and 91.9% SVR24 among this population aged 65 and older, providing potential treatment alternative for many in Japan.

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