AbbVie’s hepatitis C treatment Mavyret (glecaprevir/pibrentasvir), which works for all six genotypes of the virus, obtained approval from the U.S. Food and Drug Administration to treat children aged between 12 and 17, on Tuesday.
Mavyret is the leading hepatitis C treatment both in Korea and the world.
Mavyret is the first all-genotype hepatitis C treatment to win additional indication for children, AbbVie said.
The FDA nod was based on a study that evaluated Mavyret in 47 pediatric patients with hepatitis C virus genotypes 1 through 4 and with no or mild cirrhosis. Twelve weeks after treatment, no virus was detected in any patients who were treated with Mavyret for eight or 16 weeks
The FDA decision also reflected other studies that evaluated the efficacy and safety of Mavyret in children with cirrhosis, kidney or liver transplant history, and hepatitis C virus genotypes 5 and 6. AbbVie said it would solidify Mavyret’s dominance in the U.S. market with the latest FDA grant for not only adults but children and adolescents with hepatitis C.
Mavyret ranks first in the global hepatitis C treatment sales, two years after AbbVie received the FDA approval for the drug in 2017.
Gilead used to top the hepatitis C drug sales, holding various brands including Sovaldi, Harvoni, Epclusa, and Vocevi. However, Gilead’s No. 1 position was handed over to AbbVie’s Mavyret after a stiff competition.
AbbVie’s global sales of hepatitis C treatments Mavyret, Viekira, and Exviera marked $815 million in the first quarter, outpacing Gilead’s $790 million sales of peer drugs.
Mavyret alone sold $790 million in the January-March period. As the size of the hepatitis C treatment market is shrinking around the world, both AbbVie and Gilead suffered a sales decline. AbbVie’s revenue in hepatitis C went down 11 percent in the first quarter compared to a year earlier, and that of Gilead, 21 percent.
Despite the decrease in global sales, Mavyret sales expanded to $430 million in the U.S. in the first quarter, up 18.3 percent on-year.