The FDA has increased the acceptable uses of Bristol-Myers Squibb's Daklinza therapy.
+ Technology/Innovation
Jamie Barrand | Feb 10, 2016

FDA expands label for Bristol-Myers Squibb's Daklinza therapy

Daklinza, a product of pharmaceutical company Bristol-Myers Squibb that has been available as a treatment for chronic hepatitis C virus (HCV) genotype 3, recently received approval from the U.S. Food and Drug Administration (FDA) for additional uses.

Daklinza, an NS5A replication complex inhibitor, is now indicated for the treatment of patients with chronic hepatitis C virus, HIV-1 co-infection, advanced cirrhosis and recurrence of HCV after a liver transplant, as well.

“The expanded indication for Daklinza offers an additional treatment option for multiple subsets of patients who have genotype 1 or 3 chronic HCV,” Chris Boerner, head of U.S. commercial operations for Bristol-Myers Squibb, said. “HCV/HIV co-infected patients and patients with advanced cirrhosis or post-transplant recurrence of HCV still pose a treatment challenge to physicians. As part of our commitment to the HCV community, we have sought to make new treatment options available for these and other targeted populations that have not yet been able to fully benefit from currently available next-generation medicines.”

To date, Daklinza, taken orally once daily for 12 weeks, is the only therapy on the market for chronic HCV genotype 3.

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