FDA Approves AbbVie’s Mavyret for All Genotypes of Hep C in Pediatric Patients

The U.S. Food and Drug Administration said Tuesday it approved AbbVie Inc.’s (ABBV) Mavyret to treat all genotypes of hepatitis C virus in children ages 12 to 17.

The FDA previously approved Mavyret to treat HCV in adults in 2017.

With the latest approval, dosing information is provided 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 either without cirrhosis or with compensated cirrhosis.

The FDA said the safety and efficacy of Mavyret in pediatric patients was evaluated during clinical trials of 47 patients with genotype 1, 2, 3 or 4 HCV infection without cirrhosis or with mild cirrhosis.

https://www.marketscreener.com/ABBVIE-12136589/news/AbbVie-FDA-Approves-AbbVie-s-Mavyret-for-All-Genotypes-of-Hepatitis-C-in-Pediatric-Patients-28510868/