FDA approves MAVYRET as first treatment for acute hepatitis C

NORTH CHICAGO - The U.S. Food and Drug Administration has approved a label expansion for AbbVie’s (NYSE: ABBV) MAVYRET, making it the first and only oral treatment approved for acute hepatitis C virus (HCV) infection, according to a company press release issued Wednesday. AbbVie, a prominent player in the biotechnology industry with a market capitalization of $340 billion, continues to demonstrate strong market leadership. According to InvestingPro data, the company maintains an impressive 71% gross profit margin.

The expanded approval allows MAVYRET to be used in adults and pediatric patients three years and older with acute or chronic HCV infection. The treatment can be administered in an eight-week course for patients without cirrhosis or with compensated cirrhosis, achieving a 96% cure rate in clinical trials. With annual revenues exceeding $57 billion and positive analyst sentiment, AbbVie’s market position appears robust. InvestingPro analysis reveals 10 analysts have recently revised their earnings expectations upward for the upcoming period.

The FDA granted Breakthrough Therapy Designation for this indication, which is designed to expedite development and review of medications that may demonstrate substantial improvement over existing therapies.

The approval was supported by data from a Phase 3 multicenter study evaluating MAVYRET’s safety and efficacy in adults with acute HCV infection. The study enrolled 286 treatment-naïve patients across 70 locations globally.

HCV is a blood-borne disease that can lead to serious liver complications if left untreated. The United States is expected to incur approximately $120 billion in total medical costs over the next decade linked to chronic liver disease and other conditions caused by untreated HCV.

"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," said Roopal Thakkar, M.D., executive vice president at AbbVie. For investors seeking deeper insights into AbbVie’s financial health and growth potential, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 US stocks, including detailed metrics and expert analysis that goes beyond surface-level data.

The most common side effects reported in clinical trials were fatigue, asthenia, headache, and diarrhea, with most adverse events being mild or moderate in severity.

In other recent news, AbbVie reported significant developments in its financial and strategic operations. The company received accelerated FDA approval for EMRELIS, a treatment for advanced non-small cell lung cancer, marking a notable advancement in their oncology portfolio. This approval was based on clinical trial data showing a 35% overall response rate. In the financial arena, Guggenheim Securities raised AbbVie’s stock target to $216, citing strong first-quarter sales of Skyrizi and Rinvoq, and an updated earnings per share guidance for 2025. Meanwhile, Citi downgraded AbbVie’s stock to Neutral, adjusting the price target to $205, due to concerns about the company’s late-stage pipeline and potential policy risks. Additionally, AbbVie announced a collaboration with ADARx Pharmaceuticals to develop siRNA therapeutics, reflecting a strategic focus on innovative treatments in neuroscience, immunology, and oncology. Berenberg also adjusted their price target for AbbVie to $170, maintaining a Hold rating, while highlighting Skyrizi’s role in the company’s growth. These updates underscore AbbVie’s commitment to expanding its product offerings and enhancing its market position.

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