Enanta Pharmaceuticals and AbbVie Receive FDA Approval for Expanded Use of MAVYRET® to Treat Acute Hepatitis C
Thursday, June 12, 2025
Enanta Pharmaceuticals has announced that its partner AbbVie has received approval from the U.S. Food and Drug Administration (FDA) for an expanded indication of MAVYRET® (glecaprevir/pibrentasvir).
HCV is a contagious blood-borne virus that affects the liver. If left untreated, it can lead to serious liver problems such as cirrhosis or liver cancer. Acute HCV refers to a recent infection, which in many cases progresses to a long-term, chronic illness. Current clinical guidelines recommend that nearly all people with HCV, whether acute or chronic, should receive treatment. Broad adoption of these guidelines is expected to help limit the spread of the virus.
The treatment is now authorised for use in both adults and children aged three years and older with acute or chronic hepatitis C virus (HCV) infection, provided they do not have cirrhosis or have compensated cirrhosis. It remains the only approved eight-week treatment for this group.
The approval is based on data from a Phase 3 clinical trial evaluating MAVYRET in adults with acute HCV infection. The results showed high efficacy with most side effects reported as mild or moderate. Common side effects included fatigue, weakness, headache, and diarrhoea.
MAVYRET had previously received Breakthrough Therapy Designation from the FDA for the treatment of acute HCV. This designation is intended to speed up the development and review of medicines that may offer significant improvements over existing treatments.
Efforts led by the World Health Organization aim to eliminate HCV as a public health threat by 2030. Achieving this goal requires increased testing, treatment, and preventive measures, especially among high-risk populations.
However, recent data suggest that many high-income countries, including the United States, are not currently on track to meet this target before 2050.
Source: enanta.com
