FDA awards priority review to Bristol-Myers Squibb's filings for hepatitis C drug Daklinza

Bristol-Myers Squibb announced Tuesday that the FDA granted priority review status to marketing applications for the NS5A replication complex inhibitor Daklinza (daclatasvir) in combination with Gilead Sciences' Sovaldi (sofosbuvir) with or without ribavirin for three indications. Specifically, the filings seek approval for the treatment of patients with chronic hepatitis C (HCV) and HIV co-infection, those with advanced cirrhosis including decompensated cirrhosis, and those with post-liver transplant recurrence of HCV infection.

Douglas Manion, head of specialty development for Bristol-Myers Squibb, remarked "our focus for the Daklinza-[Sovaldi] 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."

The company noted that applications for all three indications are supported by findings from the ALLY-1 and ALLY-2 clinical trials. ALLY-1 assessed a 12-week regimen combining once-daily Daklinza and Sovaldi with ribavirin for the treatment of patients with either advanced cirrhosis or post-liver transplant recurrence of HCV, while ALLY-2 evaluated a 12-week course of Daklinza plus Sovaldi for the treatment of patients with HCV and HIV-1 co-infection.

In July, the FDA approved Daklinza in combination with Sovaldi for the treatment of patients with chronic infection with HCV genotype 3 having rejected the therapy last year. The agency additionally awarded breakthrough therapy designation to Daklinza for the treatment of HCV genotype 1 in patients with advanced cirrhosis and those who experience genotype 1 HCV recurrence post-liver transplant.

In July 2014, Daklinza was approved in Japan in combination with the NS3/4A protease inhibitor Sunvepra (asunaprevir) as the country's first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis. Daklinza has been approved in more than 50 countries, including Europe and Canada.

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