All-oral Hep C drug combo expedited toward market launch

February 24, 2014

Breakthrough Therapy Designation given to daclatasvir and asunaprevir

In late February, FDA granted  Bristol-Myers Squibb Company a Breakthrough Therapy Designation for its investigational DCV Dual Regimen (daclatasvir and asunaprevir) for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV). The designation is based on data from the company’s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.

The relatively new FDA Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions, and criteria require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

According to experts, the designation is seen as a positive sign that FDA is ensuring that innovative drug products are brought to market even more quickly for the millions of patients with serious medical conditions. More than 3 million people are estimated to have HCV in the United States.

Express Scripts predicts that HCV drug trend will grow by 168% in 2015. The emerging therapies offer 95% or higher sustained virologic rates and are rapidly becoming standard care.