Enanta Pharmaceuticals’ Partner AbbVie Receives European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus

About this update from Enanta Pharmaceuticals, Inc.

WATERTOWN, Mass., June 23, 2026--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the European Commission has approved MAVIRET® (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy, for the treatment of acute HCV infection without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older. MAVIRET is now the only treatment approved in the European Union (EU) for both acute and chronic HCV infection. "The European Commission’s approval of MAVIRET for acute HCV infection is a meaningful step for the more than 12 million individuals in Europe living with HCV, by enabling earlier treatment and supporting timely intervention at a stage when the disease may be asymptomatic and can go undetected," said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. "Given acute HCV is typically diagnosed incidentally, starting treatment before a patient has advanced to chronic HCV can be difficult. Today’s approval supports public health efforts by accelerating treatment, reducing transmission and addressing unmet need. We take pride in the role our discovery of glecaprevir has played in bringing forward a therapy that continues to benefit HCV patients worldwide. We are pleased that AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people who have acute HCV infection." The EU approval for acute HCV infection was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET eight-week treatment in patients with acute HCV infection.1 The study results showed MAVIRET to be a highly efficacious treatment for people with acute HCV.1 The majority of the adverse events reported were mild or moderate in severity.1 The most common adverse events were fatigue, diarrhea, headache, and asthenia.1 HCV is a highly infectious, blood-borne disease that affects the liver and if left untreated can lead to serious complications, including liver cirrhosis and cancer.2 Acute HCV infection is frequently asymptomatic and many people remain unaware of the infection until it has progressed to a later stage.2 Clinica...

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