FDA grants priority review for HCV treatment Daklinza sNDAs

The US Food and Drug Administration (FDA) has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Bristol-Myers Squibb’s Daklinza (daclatasvir).

Daklinza, a core agent in Bristol-Myers Squibb’s hepatitis C virus (HCV) treatment portfolio, is an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin. The applications are for the treatment of patients with chronic 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.

“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,” said Douglas Manion, M.D., head of Specialty Development, Bristol-Myers Squibb. “We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients.”

Daklinza sNDAs include data from the ALLY-1 and ALLY-2 clinical trials

Daklinza was initially approved in the US earlier this year and is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection. The new sNDAs accepted by the FDA for review include data from the ALLY-1 and ALLY-2 clinical trials. ALLY-2 evaluated the once-daily 12-week combination of Daklinza and sofosbuvir for the treatment of patients with HCV coinfected with HIV-1. Among ALLY-2 patients treated for 12 weeks, 97% achieved cure (sustained virologic response 12 weeks after treatment; SVR12). 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. The ALLY-1 trial results demonstrated that the daclatasvir-based regimen cured 94% of post-liver transplant patients with HCV and up to 94% of HCV patients with cirrhosis.

In May 2015, Daklinza with sofosbuvir received FDA Breakthrough Therapy Designation 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.