Updated on 4 November 2013
This is the first time that any drugmaker has filed for approval with Japan’s Pharmaceutical and Medical Devices Agency for a hepatitis C treatment regimen that does not include either of the standard older treatments
Singapore: US drugmaker, Bristol-Myers Squibb co has said that it is seeking Japanese health regulators approval of its experimental all-oral combination of hepatitis C treatments.
This is the first time that any drugmaker has filed for approval with Japan's Pharmaceutical and Medical Devices Agency for a hepatitis C treatment regimen that does not include either of the standard older treatments - the injected, difficult-to-tolerate interferon, or ribavirin, a pill.
The Bristol-Myers filing was based on data from a Phase III study of Japanese patients who either could not tolerate interferon, which causes miserable flu-like symptoms, or those who had previously failed to be helped by treatment with the older drugs - a particularly tough-to-treat patient population.
Patients in the trial were given a combination of daclatasvir, from a promising new class of drugs called NS5A inhibitors, and the protease inhibitor asunaprevir for 24 weeks. Those who had no detectable levels of the virus in their blood 24 weeks after completing the therapy were deemed to be cured, a measure known as SVR24, for sustained virologic response.
The overall cure rate in the 222 patient study was 84.7 percent, according to the data to be presented next week at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington.