The US Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for Bristol-Myers Squibb’s investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. The updated designation reflects recently presented data on HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant. Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates a drug may have substantial improvement on at least one clinically significant endpoint over available therapies.

According to the FDA, Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The FDA first granted a designation for the daclatasvir and sofosbuvir combination in 2014; since that time, there have been significant developments in the field of HCV. That has led the FDA to review, modify, and in some cases, rescind previously granted HCV-related designations.

“Our daclatasvir clinical development program focuses on addressing high unmet medical needs still encountered in the treatment of hepatitis C despite the advent of new therapies,” said Douglas Manion, M.D., head of specialty development, Bristol-Myers Squibb, in a company statement. “This designation recognizes the importance of developing a new treatment option for post-liver transplant and cirrhotic patients, who are among the most challenging patient populations to treat with currently available regimens.”

Source: Bristol-Myers Squibb