FDA Accepts BMS’ sNDAs for Hepatitis C Drug

The US Food and Drug Administration (FDA) has accepted for filing and review three supplemental new drug applications (sNDAs) for Daklinza (daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin for treating various forms chronic hepatitis C (HCV). The indications are for treating patients coinfected with human immunodeficiency virus (HIV-1), patients with advanced cirrhosis (including decompensated cirrhosis), and for patients with post-liver transplant recurrence of HCV.

In the US, the FDA grants priority review status when an investigational medicine, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. The FDA will review the three Daklinza sNDAs within a six-month timeframe.

Daklinza was initially approved in the US in July 2015 and is indicated for use with sofosbuvir for the treatment of patients with chronic HCV genotype 3 infection.

n 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. Breakthrough therapy designation, according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for this designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.

Source: Bristol-Myers Squibb

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