FDA clears hepatitis C drug Mavyret
SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug to treat adults with chronic hepatitis C virus genotypes 1-6. Mavyret, from AbbVie, was approved for HCV patients without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those on dialysis.
The FDA said that Mavyret is the first treatment of eight-week duration for all hepatitis C genotypes.
“This approval provides a shorter treatment duration for many patients, and also a treatment option for certain patients with genotype 1 infection, the most common HCV genotype in the United States, who were not successfully treated with other direct-acting antiviral treatments in the past,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
AbbVie EVP research and development and chief scientific officer Dr. Michael Severino said, “The approval of Mavyret demonstrates AbbVie's commitment to advancing science to help address unmet needs by delivering a new cure for patients who historically had limited treatment options.”