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Enanta & AbbVie FDA Approval for Expanded Use of MAVYRET®

13 Jun 2025
Admin
News Article

Enanta & AbbVie FDA Approval for Expanded Use of MAVYRET®

Enanta Pharmaceuticals and AbbVie Receive FDA Approval for Expanded Use of MAVYRET® to Treat Acute Hepatitis C

Overview

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).

About the HCV

• 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.

Threatment Authorization & results

• 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 & BTD

• 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.

WHO goals

• 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.

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