AbbVie's chronic hepatitis C virus (HCV) infection drug, Maviret, was granted a positive opinion by the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
"Maviret represents a new generation of HCV therapy and has the potential to be a shorter, 8-week option for patients living with this serious, chronic illness," Dr. Michael Severino, executive vice president of research and development and chief scientific officer at AbbVie, said in a statement. "Today's CHMP positive opinion takes us closer to delivering on AbbVie's mission to address continued unmet needs by bringing a new pan-genotypic option to people living with HCV in Europe."
AbbVie noted that the EMA is giving an accelerated assessment to the marketing authorization application for Maviret. If approved, AbbVie will be able to market the product in all 28 member states of the European Union, as well as Iceland, Liechtenstein and Norway.
"While the HCV treatment landscape has transformed significantly over recent years, the disease continues to be a global public health problem and treatment challenges remain," Dr. Stefan Zeuzem, chief of the department of medicine at the J.W. Goethe University Hospital in Frankfurt, Germany, said. "In clinical studies, Maviret demonstrated high SVR rates across all genotypes of HCV patients (GT1-6). If approved, Maviret would remove many of the complexities of pre-treatment patient evaluation and have the potential to help facilitate the care and management of HCV.”
Alerts Sign-up