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news.Bristol-Myers Squibb's three supplemental new drug applications (sNDAs) have been accepted for filing and review by the US Food and Drug Administration (FDA) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.
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The sNDAs can be used for the treatment of patients with chronic hepatitis C (HCV) coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.
According to the FDA, within a six-month timeframe it will review the three Daklinza sNDAs.
Bristol-Myers Squibb Specialty Development head Douglas Manion said: "Hepatitis C is not a one-size-fits-all, monolithic disease.
"Our focus for the Daklinza-sofosbuvir regimen centers on addressing the needs of HCV patient subpopulations who need new options even in light of the extraordinary advances that have occurred in HCV treatment.
"We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients."
This July, Daklinza was initially approved in the US for use with sofosbuvir to treat patients with chronic HCV genotype 3 infection.
The new sNDAs accepted by the FDA for review were based on data from the ALLY-1 and ALLY-2 clinical trials.
ALLY-2 assessed the once-daily 12-week combination of Daklinza and sofosbuvir to treat patients with HCV coinfected with HIV-1, while the ALLY-1 trial evaluated a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin in patients with HCV with either advanced cirrhosis or post-liver transplant recurrence of HCV.
Last July, Japan became the first country to approve the use of a daclatasvir-based regimen for the treatment of chronic HCV.