PRINCETON, N.J.–(BUSINESS WIRE)–May 20, 2015–Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the 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 therapy.
The designation is supported by data from ALLY-1, a Phase III clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV. Results from ALLY-1 were recently presented at The International Liver Congress™ 2015, this year’s annual meeting of the European Association for the Study of the Liver.
“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. “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.”
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 2013; 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.