Bristol-Myers Squibb, a global pharmaceutical company headquartered in New York, NY, announced that the US Food and Drug Administration has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.  Hepatitis C is a virus that targets the liver.  Up to 90% of people infected with hepatitis C will not spontaneously clear the virus and will become chronically infected which could lead to cirrhosis and some may progress to liver cancer.  According to the company’s website, this designation is supported by data from 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.

 

Original Article:

  1. http://news.bms.com/press-release/bristol-myers-squibb-receives-amended-us-fda-breakthrough-therapy-designation-investig