The U.S. Food and Drug Administration approved AbbVie Inc.'s Mavyret, a combination of glecaprevir and pibrentasvir, to treat all six major genotypes of chronic hepatitis C.
The approval is based on data from nine studies, evaluating more than 2,300 patients in 27 countries.
Glecaprevir is being developed by AbbVie and Enanta Pharmaceuticals Inc. The approval makes Enanta eligible for a $40 million milestone payment from AbbVie.
AbbVie recently reported positive results for the phase 3 trial evaluating glecaprevir/pibrentasvir in chronic hepatitis C patients with compensated cirrhosis.
The drug's approval follows a breakthrough therapy designation by the FDA to treat of one form of the disease. Mavyret also has European approval for the treatment of all types of chronic hepatitis C.