Breakthrough Designation for daclatasvir and sofosbuvir combination is supported by the recently presented ALLY-1 trial in patients with advanced cirrhosis or recurrent hepatitis C (HCV) after liver transplant.
FDA Designation signifies that high unmet need still exists among these patient populations despite other available therapies.
This Designation is separate from the FDA’s ongoing NDA review of a daclatasvir-sofosbuvir regimen for the treatment of patients with genotype 3 HCV .
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) 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 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.
About Hepatitis C
Hepatitis C is a virus that infects the liver. It spreads through direct contact with infected blood and blood products. Approximately 170 million people worldwide are infected with hepatitis C. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 20 percent may progress to liver cancer.
About Bristol-Myers Squibb in HCV
Bristol-Myers Squibb’s hepatitis C research and clinical development efforts center on patients with high unmet medical needs. At the core of its portfolio is daclatasvir, a NS5A complex inhibitor being investigated in multiple treatment regimens and patient populations. The Phase III ALLY Trial Program was established to study the combination of daclatasvir and sofosbuvir in various HCV high-unmet need patient subtypes, including patients with HCV genotype 3, pre- and post-transplant patients and HIV/HCV coinfected patients.
In July 2014, Japan became the first country in the world to approve the use of a daclatasvir-based regimen for the treatment of hepatitis C. Since then, daclatasvir-based regimens have been approved across Europe, as well as numerous other countries in Central and South America, the Middle East and the Asia-Pacific region.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Bristol-Myers Squibb Forward Looking Statement
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that daclatasvir will receive regulatory approval in the United States, or if approved, that it will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2014, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.