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FDA has approved Mavyret (glecaprevir and pibrentasvir), a new molecular entity (NME), to treat chronic hepatitis C virus (HCV).
On August 3, 2017, FDA approved Mavyret (glecaprevir and pibrentasvir) to treat chronic hepatitis C virus (HCV). With an eight-week duration treatment compared to the standard 12-week or more duration, the drug is approved to treat all genotypes of HCV.
“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, MD, FDA’s director of the Office of Antimicrobial Products of CDER, in a company press release.
Hepatitis C, a viral disease, causes liver inflammation that can lead to liver damage or failure. With a 92-100% cure rate during trials, treatment duration of the drug varies depending on treatment history, viral genotype, and cirrhosis status of patients.
"The clinical trial program for Mavyret resulted in high cure rates across a range of patient populations, from those who have never been treated and who do not have cirrhosis, all the way to patients with compensated cirrhosis," said Fred Poordad, MD, vice president, academic and clinical affairs, Texas Liver Institute and professor of medicine, University of Texas Health, San Antonio, in a company press release. "This approval helps achieve physicians' goals of delivering effective options for a broad range of patients."
FDA approval has been granted to AbbVie. Glecaprevir, one of the active ingredients in the drug, was the result of an ongoing partnership between AbbVie and biotechnology company Enanta Pharmaceuticals (US).