Daklinza Hepatitis C Drug Seeks Label Expansion


The FDA is considering expanding the use for a drug currently indicated as a chronic hepatitis C (HCV) treatment.

The FDA is considering expanding the use for a drug currently indicated as a chronic hepatitis C (HCV) treatment.

Bristol-Myers Squibb’s 3 supplemental New Drug Applications (sNDAs) for daclatasvir (Daklinza) for use with sofosbuvir with or without ribavirin were recently granted priority review status.

The 3 applications seek a label expansion for treating patients co-infected with HCV and human immunodeficiency virus (HIV), patients with advanced cirrhosis, and patients with post-liver transplant recurrence of HCV.

Daklinza was initially approved for use with sofosbuvir in July 2015 to treat HCV genotype 3 infection.

“Hepatitis C is not a one-size-fits-all, monolithic disease,” said Douglas Manion, head of specialty development at Bristol-Myers Squibb, in a press release. “Our focus for the Daklinza-sofosbuvir regimen centers 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. We look forward to working with the FDA toward the goal of eventually helping many difficult-to-treat HCV patients.”

Adverse effects associated with Daklinza include headache, fatigue, nausea, and diarrhea.

Daklinza has not been studied in women who are pregnant or nursing.

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