News Feature | March 5, 2014

FDA Gives Bristol-Myers' Daclatasvir And Asunaprevir Breakthrough Designation For Hepatitis C

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By Cyndi Root

Bristol-Myers Squibb Company announced in a press release that the Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for a daclatasvir and asunaprevir drug combination. The treatment is intended for chronic hepatitis C infection (HCV). The approval was based on ongoing phase 3 trials of the drug combination. Brian Daniels, MD, Senior Vice President, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb, said, “The FDA’s decision to grant Breakthrough Therapy Designation for our DCV Dual Regimen (daclatasvir and asunaprevir combination therapy) marks the second time that the FDA has granted the Designation to a daclatasvir-based regimen, further underscoring its potential to help address the high unmet needs of the HCV patient population.”  

Hepatitis C Infection

HCV is caused by the hepatitis C virus, transmitted through blood. Some people have only mild symptoms, while others develop serious and life-long complications. Some may develop cirrhosis of the liver, while others may contract liver cancer. About 150 million people have the virus and over 300,000 people die each year. Up to four million people in the U.S. have the disease. Currently, no vaccines are available, but antiviral medicines offer some treatment.

Daclatasvir And Asunaprevir

Daclatasvir (DCV) And Asunaprevir (ASV) are approved in combination. Data from clinical studies that the FDA relied on for approval will be published and presented soon. DCV is a NS5A replication complex inhibitor. ASV is a NS3 protease inhibitor. DCV  has been studied in over 5,000 patients and is being studied in combination with other drugs including a Japanese study of HCV genotype 1b.

The European Medicines Agency (EMA) has approved Bristol-Myers Squibbs’  marketing authorization application (MAA) for DCV. It is indicated for HVC genotypes 1, 2, 3, and 4 and for those with liver disease. The agency is evaluating DCV for combination use with other agents under accelerated regulatory review.

About Bristol-Myers Squibbs

Bristol-Myers Squibbs focuses its research efforts on late-stage compounds for serious diseases. The company is currently conducting clinical trials and initiating others for DCV in combination with sofosbuvir. Other agents under investigation include Asunaprevir, BMS-791325, and Peginterferon lambda.