BMS Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Regimen
Cinnamon Girl said
Feb 25, 2014
Monday, February 24, 2014 PRINCETON, N.J. - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV. The designation is based on data from the company`s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.
Monday, February 24, 2014 PRINCETON, N.J. - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has granted its investigational DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b HCV. The designation is based on data from the company`s ongoing Phase III clinical trial program evaluating the all-oral combination regimen of DCV, an investigational NS5A replication complex inhibitor, and ASV, an investigational NS3 protease inhibitor, without ribavirin.
Full press release...
http://news.bms.com/press-release/bristol-myers-squibb-receives-us-fda-breakthrough-therapy-designation-all-oral-daclata&t=635288455840568400