FDA Grants Breakthrough Designation to Investigational Combination Treatment for Type-1b Chronic Hepatitis C Infection

This article was originally published on the Specialty Pharmacy Times website.

The FDA has granted breakthrough therapy designation to a combination of daclatasvir (DCV) and asunaprevir (ASV) in development by Bristol-Myers Squibb (BMS). The FDA’s decision reflects positive preliminary results with the combination in patients with genotype 1b chronic hepatitis C infection (HCV).

To promote innovation, the breakthrough therapies designation was created on July 9, 2012, through passage of the Food and Drug Administration Safety and Innovation Act. Breakthrough therapies treat a serious or life-threatening disease, and have the support of preliminary clinical evidence indicating that the drugs may represent a meaningful improvement over currently available treatments. Drugs designated as breakthrough therapies also undergo an expedited review process.

Although BMS announced that results of the US trial would soon be released at a scientific forum, the DCV/ASV combination has already undergone phase-3 trials in Japanese patients with genotype 1b HCV who failed to achieve cure with interferon or were intolerant to or ineligible for interferon therapy.

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