U.S. FDA Approves Expanded Indication for AbbVie's MAVYRET as First and Only Treatment for People with Acute Hepatitis C Virus

Published: 2025-06-12 10:28:00 ET ABBV

Published on 06/12/2025 at 10:28

NORTH CHICAGO - AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) approved a label expansion for MAVYRET, 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 the first and only DAA therapy approved to treat patients with acute HCV in eight weeks with a 96% cure rate.

HCV is a highly infectious blood-borne disease affecting the liver.1 People recently infected, or those with acute HCV, may not have symptoms.1 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.4 Widespread implementation of these guidelines has the potential to substantially reduce the global spread of the disease.4 Additionally, the public health community has set a goal to eliminate HCV by 2030.5 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.7

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.2 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. The most common adverse events were fatigue, asthenia, headache, and diarrhea.

About the Phase 3 M20-350 Study8

The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVYRET (glecaprevir/pibrentasvir) eight-week treatment in adults and pediatric patients with acute HCV infection. The study enrolled 286 treatment-naive adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVYRET once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR12) in the Intention-to-Treat (ITT) population. Secondary endpoints included the percentage of patients achieving SVR12 in the Modified ITT-Virologic Failure (mITT-VF) population, and the percentage of patients with on-treatment virologic failure and post-treatment relapse in the ITT population.

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology, neuroscience and eye care and products and services in our Allergan Aesthetics portfolio.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words 'believe,' 'expect,' 'anticipate,' 'project' and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, 'Risk Factors,' of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

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