Bristol-Myers Squibb landed a Breakthrough Therapy designation for its daclatasvir + asunaprevir combination to treat genotype 1b hep. C. The regulator granted the designation based on Phase-III clinical data involving the all-oral, two-drug regimen.
If the drug mix sounds familiar, it is: the FDA granted Breakthrough Therapy status in October 2013 to an all-oral combination of daclatasvir, asunaprevir and BMS-791325, which is being studied in non-cirrhotic, treatment-naïve and experienced patients, as well as cirrhotic, treatment naïve and experienced patients.
