AbbVie Inc. said the European Commission has expanded marketing approval for Mavyret to include an additional indication of hepatitis C.
The expansion will cover a once-daily eight-week treatment option of Mavyret for patients with hepatitis C who do not respond to treatment and have a scarred liver that still has basic organ functionality. Previously the treatment was approved by the European regulator for hepatitis C patients without liver scarring.
The new marketing authorization is based on data from an ongoing Phase 3b study called Expedition-8. As part of the trial, blood samples were tested 12 weeks after the treatment ended and no virus was detected in 97.9% of patients with genotypes 1, 2, 4, 5 and 6 who received Mavyret. Genotypes are categories of infection based on similar genes and each genotype responds differently to medicines.
Mavyret is a combination of glecaprevir and pibrentasvir and is sold in the EU and Japan as Maviret.
AbbVie developed glecaprevir in collaboration with Enanta Pharmaceuticals Inc., a Watertown, Mass.-based biotechnology company that develops small molecule drugs for the treatment of viral infections and liver diseases.
Both companies agreed to work together to discover hepatitis C virus treatments in December 2006. Glecaprevir is the second protease inhibitor developed and commercialized by Abbvie under this collaboration.
The U.S. Food and Drug Administration originally approved the drug to treat all six major genotypes of adult hepatitis C patients without liver scarring in August 2017.
The FDA allowed the therapy for children ages 12 to 17 in April with instructions to screen patients for the hepatitis B virus before treatment. There have been reports of hepatitis B virus reactivation— an abrupt increase in replication of the virus — in co-infected patients treated only with antivirals for hepatitis C.