BioCentury
ARTICLE | Clinical News

BMS's oral HCV combo under review in China

February 23, 2016 2:39 AM UTC

Bristol-Myers Squibb Co. (NYSE:BMY) presented data from an open-label Phase III trial evaluating a combination of its HCV drugs Daklinza daclatasvir plus Sunvepra asunaprevir in non-Japanese Asian patients with chronic HCV genotype 1b, and disclosed that Chinese regulatory authorities have accepted an NDA seeking approval of the all-oral regimen in the indication based on the data. Spokesperson Rob Perry said BMS has not received an approval timeline from Chinese regulatory authorities.

BMS said Daklinza plus Sunvepra for 24 weeks led to an SVR24, the primary endpoint, in 91% of Chinese patients. The trial enrolled 159 treatment-experienced and treatment-naive patients, 80% of whom were from mainland China. In Chinese patients without NS5A resistance-associated variants (RAVs) at baseline, the SVR24 rate was 98%. ...