BMS Files for Approval of Daclatasvir, Asunaprevir for Hepatitis C

Drug giant Bristol-Myers Squibb said Monday it has submitted new drug applications for its hepatitis C drug candidates daclatasvir and asunaprevir for the treatment of genotype 1b.

Daclatasvir, an investigational NS5A replication complex inhibitor, is at the center of BMS’ hepatitis C pipeline. Data from multiple Phase III studies, including the Hallmark-Dual study showing DCV/ASV achieved a functional cure among many genotype 1b patients, support the use of the drugs together and in conjunction with other therapies to treat a wide range of patients across multiple hepatitis C genotypes, BMS said.

DCV also is being evaluated as part of a fixed-dose, twice-daily oral triple direct antiviral agent (3DAA) regimen in combination with ASV and BMS-791325 in noncirrhotic naïve, cirrhotic naïve and previously treated patients.

The FDA has designated both the DCV/ASV and 3DAA formulations as breakthrough therapies. BMS is hoping to submit the latter for review in the first quarter of next year.

DCV is under accelerated review in the EU for HCV patients with compensated liver disease, including genotypes 1, 2, 3 and 4. Japan’s regulator has also granted the drug priority review.

BMS said it is also studying DCV in combination with sofosbuvir in patients with high unmet need. Sofosbuvir has become the latest trend in hepatitis C therapy since Gilead Sciences released Sovaldi following FDA approval in December for all but genotype-1. A combination of Sovaldi and Gilead’s ledipasvir is currently under priority review in the U.S. — Lena Freund

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