The US Food and Drug Administration (FDA) has accepted filing and review of Bristol-Myers Squibb‘s three supplemental new drug applications (sNDAs) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.
Approval is being sought for the sNDAs for Daklinza to treat 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.
The FDA said that 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 centres 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."
In 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 evaluated 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.
In May, Daklinza with sofosbuvir received breakthrough therapy designation from the FDA to treat HCV genotype 1 patients with advanced cirrhosis (Child-Pugh Class B or C) and those who develop genotype 1 HCV recurrence post-liver transplant.
The company said that Daklinza is indicated for use with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection.
In July, Japan became the first country to approve the use of a daclatasvir-based regimen for the treatment of chronic HCV.
Following Japanese approval, daclatasvir-based regimens have been approved in more than 50 countries, including the US, across Europe, and in several other countries in Central and South America, the Middle East and the Asia-Pacific region.