FDA Grants Priority Review for Daklinza

The U.S. Food and Drug Administration (FDA) will review Daklinza (daclatasvir) for use with Sovaldi (sofosbuvir) and with or without ribavirin for the treatment of patients with chronic hepatitis C (HCV) co-infected with HIV, patients with advanced cirrhosis including decompensated cirrhosis, and patients with HCV recurrence after undergoing liver transplant.

The FDA granted the treatment a priority review, and will review within a six month timeframe. The FDA can grant priority review status to treatments, which if approved, could potentially offer advanced results over current options.

Bristol Myers Squibb, manufacturer of Daklinza, applied for FDA review after supportive results came out of clinical trials where Daklinza in combination with sofosbuvir and with ribavirin was used for the treatment of HCV genotype 1 patients with advanced cirrhosis and Daklinza combined sofosbuvir was used for the treatment of patients co-infected with HCV and HIV.

Daklinza with sofosbuvir was approved in July for the treatment of HCV genotype 3 patients. The FDA also designated breakthrough therapy status for Daklinza for the treatment of HCV genotype 1 patients with advanced cirrhosis and patients with HCV genotype 1 recurrence after liver transplant.

Daklinza is a NS5A replication complex inhibitor. Bristol-Myers Squibb will continue to investigate the treatment’s use in other regimens.1-3

For more information, visit the press release from Bristol-Myers Squibb.

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