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news.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 to treat patients with hepatitis C (HCV).
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The company said that the updated breakthrough therapy 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.
The breakthrough therapy status was based on data from ALLY-1, a Phase III trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin to treat patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.
Bristol-Myers Squibb Specialty Development head Douglas Manion said: "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.
"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."
The FDA breakthrough therapy status will expedite the development and review of drugs for serious or life-threatening conditions.
The agency first granted a breakthrough therapy designation for the daclatasvir and sofosbuvir combination in 2013 and since then, there have been significant developments in the field of HCV.