Enanta Pharmaceuticals, Inc. Announces EMA Grants Accelerated Assessment, Validates Marketing Authorization Application for Abbvie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C
January 24, 2017 at 04:05 am
Share
Enanta Pharmaceuticals, Inc. announced that AbbVie’s marketing authorization application (MAA) for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes, has been validated by the European Medicines Agency (EMA) and is now under accelerated assessment. If approved, G/P may provide shorter treatment duration for patients infected with any of HCV genotypes 1-6 (GT1-6) and without cirrhosis, who represent the majority of HCV patients. G/P is also intended to provide an additional treatment option to patients with compensated cirrhosis (Child Pugh A) and to address the needs of patients with specific treatment challenges, including those with severe chronic kidney disease (CKD) and those not cured with previous direct-acting-antiviral (DAA) treatment. The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the EMA, will review the G/P regimen under accelerated assessment, which is the EMA’s designation for new medicines of major public health interest and therapeutic innovation, and is designed to bring new treatments to patients more quickly. Validation of the MAA confirms that the submission is complete and starts the EMA's centralized review process. If approved, AbbVie's G/P regimen could become available for marketing in the European Union (EU) in the second half of 2017. The MAA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across all major HCV genotypes and several special populations. Patient populations studied included GT1-6, those new and experienced to treatment, those with compensated cirrhosis and without cirrhosis, and those with specific treatment challenges, including those with severe CKD, and those not cured with a prior DAA-containing regimen. The program was designed to investigate a faster path to virologic cure for all major HCV genotypes (GT1-6) and with the goal of addressing areas of continued unmet need.
Enanta Pharmaceuticals, Inc. is a clinical-stage biotechnology company dedicated to creating small molecule drugs with an emphasis on indications in virology and immunology. The Company's research and development programs are focused on respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU). The Company discovered glecaprevir, the second of two protease inhibitors discovered and developed through its collaboration with AbbVie for the treatment of chronic infection with hepatitis C virus (HCV). Glecaprevir is co-formulated as part of AbbVie's direct-acting antiviral (DAA) combination treatment for HCV, which is marketed under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.) (glecaprevir/pibrentasvir). Its research and development programs are in virology, namely RSV, SARS-CoV-2 and hepatitis B virus. The Company has a research program targeting development of single agents with broader spectrum antiviral activity against both RSV and human metapneumovirus (hMPV).
Enanta Pharmaceuticals, Inc. Announces EMA Grants Accelerated Assessment, Validates Marketing Authorization Application for Abbvie’s Investigational HCV Regimen of Glecaprevir/Pibrentasvir (G/P) for the Treatment of All Major Genotypes (GT1-6) of Chronic Hepatitis C