Friday, AbbVie Inc. (ABBV) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the approval of MAVIRET for the treatment of acute hepatitis C infection in adults and children aged 3 years and older.
If approved, MAVIRET would be indicated for both acute and chronic hepatitis C infection in the European Union. Notably, the final decision is expected in the third quarter of 2026.
The positive opinion is supported by data from the Phase 3, which evaluated the safety and efficacy of MAVIRET eight-week treatment in adults with acute HCV infection.
During the study, MAVIRET demonstrated a 96% cure rate, as measured by sustained virologic response at 12 weeks after treatment.
In the pre-market hours, ABBV is trading at $214.00, down 0.27 percent on the New York Stock Exchange.
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