FDA accepts re-submission of daclatasvir + sofosbuvir combination for treatment of hepatitis C genotype 3- BMS

BMS announced that the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the FDA for use in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.

The original NDA has been amended to include data from the Phase III ALLY-3 trial, which showed high cure rates for the combination, with sustained virologic response 12 weeks after treatment (SVR12) in 90% of treatment-naïve and 86% of treatment-experienced genotype 3 HCV patients. SVR12 rates were higher (96%) in non-cirrhotic genotype 3 patients, regardless of treatment history. The FDA will now review the submission within a six-month timeframe. The daclatasvir-based NDA seeks to address a high-unmet patient need that still exists despite recent hepatitis C treatment advances. Approximately 9-12% of HCV patients in the U.S. have genotype 3. That is thousands of individuals in the U.S. who historically have had limited treatment options requiring at least 24 weeks of treatment.