FDA to Review Three Daklinza sNDAs for HCV Infection
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir) for use with sofosbuvir with or without ribavirin for the treatment of patients with chronic hepatitis C (HCV) co-infected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
The sNDA submissions were based on data from two clinical trials. ALLY-1 evaluated a 12-week regimen of daclatasvir and sofosbuvir once daily with ribavirin for the treatment of patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV. ALLY-2 evaluated the once daily 12-week combination of Daklinza and sofosbuvir for the treatment of patients with HCV co-infected with HIV-1. The FDA will review the three Daklinza sNDAs within a six-month timeframe.
Daklinza, an NS5A replication complex inhibitor, in combination with sofosbuvir, was initially approved in July 2015 for the treatment of patients with chronic HCV genotype 3 infection. Daklinza with sofosbuvir received Breakthrough Therapy designation in May 2015 for HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant.
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