USFDA approves expanded indication for AbbVie Mavyret for Acute Hepatitis C Virus
North Chicago: AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for a label expansion for MAVYRET (glecaprevir/pibrentasvir), an oral pangenotypic direct acting antiviral (DAA) therapy.
It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis. With this approval, MAVYRET is now a DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate. 2,â€
HCV is a highly infectious blood-borne disease affecting the liver. People recently infected, or those with acute HCV, may not have symptoms. If left untreated, HCV could lead to liver-related complications, such as cirrhosis or liver cancer. The United States is expected to incur ~$120 billion in total medical costs over the next 10 years through 2035 linked to chronic liver disease and other related conditions caused by untreated HCV.
"The physical, emotional, and economic burden of a curable condition like hepatitis C is far too great in the United States and around the world," said John Ward, M.D., director, Coalition for Global Hepatitis Elimination. "If treated early with safe and effective therapies, providers can cure virtually all patients with hepatitis C before it escalates to chronic disease and eventually cirrhosis or liver cancer. The public health community now has a good opportunity to cure nearly all persons to support eliminating the toll of this deadly virus. No one should die of hepatitis C."
Current global clinical guidance calls for the universal treatment of nearly all people with acute or chronic HCV infection. Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease. Additionally, the public health community has set a goal to eliminate HCV by 2030. Nearly 80% of high-income countries, including the U.S., are not on track to achieve this goal until after 2050.
"MAVYRET has treated more than one million patients with HCV, but we recognize that a significant need remains for patients with acute infection," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. "The label expansion for MAVYRET, coupled with the implementation of test and treat models of care, serve as tools to support the public health community in treating more patients and bringing us closer to achieving the global 2030 elimination goal."
The FDA granted Breakthrough Therapy Designation (BTD) for MAVYRET for the treatment of acute HCV. The BTD program is designed to expedite the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The label expansion was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVYRET eight-week treatment in adults with acute HCV infection. The study results showed MAVYRET to be a highly efficacious treatment for people with acute HCV. The majority of the adverse events reported were mild or moderate in severity.
