Watertown, Mass. — Enanta Pharmaceuticals said its partner AbbVie has received European Commission approval for MAVIRET to treat acute hepatitis C virus infection in adults and children ages 3 and older without cirrhosis or with compensated cirrhosis.
The approval makes MAVIRET, or glecaprevir/pibrentasvir, the only treatment authorized in the European Union for both acute and chronic hepatitis C infection.
MAVIRET is an oral, pangenotypic direct-acting antiviral therapy. Glecaprevir, one of the treatment’s two antiviral components, was discovered by Enanta and subsequently developed and commercialized by AbbVie.
“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 approval was supported by results from the Phase 3 M20-350 study, a multicenter, single-arm trial evaluating eight weeks of MAVIRET treatment in patients with acute hepatitis C.
The study enrolled 286 treatment-naive adults with acute hepatitis C across 70 sites worldwide. Participants received MAVIRET orally once a day for eight weeks and were monitored for 12 weeks after completing treatment.
The trial met its primary endpoint, with 96.2% of patients in the intent-to-treat population achieving a sustained virologic response 12 weeks after treatment. The key secondary endpoint was also met, with 100% of patients in the modified intent-to-treat virologic failure population achieving a sustained response.
No serious adverse reactions or adverse reactions resulting in treatment discontinuation were observed. The most commonly reported adverse reactions were fatigue, asthenia, headache and diarrhea.
No patients experienced virologic failure during treatment or relapse after treatment. Post-treatment reinfection occurred in 0.7% of patients.
Hepatitis C is a blood-borne viral infection affecting the liver. Acute infection is frequently asymptomatic and can remain undetected until it progresses to chronic disease. Without treatment, hepatitis C can lead to serious complications, including cirrhosis and liver cancer.
