FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Approves AbbVie’s Hep C Antiviral for Pediatric Use

May 8, 2019

The FDA approved AbbVie’s Mavyret (glecaprevir and pibrentasvir) tablets to treat all genotypes of hepatitis C virus (HCV) in children ages 12 to 17.

In clinical trials of 47 pediatric patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with only mild cirrhosis, all patients who received the treatment for eight or 16 weeks had no virus detected in the blood 12 weeks after finishing treatment.

The approval comes with new dosing information for Mavyret for the treatment of adult or pediatric patients 12 years and older, or weighing at least 99 pounds, who are infected with any of six identified HCV genotypes. The agency approved Mavyret for treatment of adults in 2017.

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