AbbVie's MAVIRET® Secures Positive Recommendation for Acute Hepatitis C Treatment in Europe
AbbVie's MAVIRET® Receives Positive CHMP Opinion for Acute Hepatitis C Treatment
AbbVie, a leading global biopharmaceutical company, recently announced a significant milestone in its ongoing efforts to combat hepatitis C. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has provided a positive opinion recommending the approval of MAVIRET® (glecaprevir/pibrentasvir) for the treatment of acute hepatitis C infection among adults and children aged three years and older. This endorsement marks a progressive step towards enhancing treatment accessibility and improving outcomes for individuals diagnosed with this serious viral infection.
Clinical research has shown that acute hepatitis C is often asymptomatic, making early diagnosis and treatment imperative for successful intervention. The recommendation for MAVIRET is bolstered by robust data from the Phase 3 M20-350 study, which investigated the safety and efficacy of an eight-week treatment regimen in adults with acute hepatitis C. This multicenter, single-arm trial enrolled 286 treatment-naïve adult participants across 70 locations globally, yielding a remarkable 96.2% cure rate, as evidenced by a sustained virologic response 12 weeks post-treatment.
Dr. Primal Kaur, AbbVie's Senior Vice President for Global Development, expressed that
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