AbbVie’s Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation : prnewswire

according to prnewswire

AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie."The FDA's Breakthrough Therapy Designation is an important step in our effort to bring our pan-genotypic regimen to market, which we are also investigating as an eight week path to virologic cure for the majority of patients."AbbVie will present new Phase 3 data evaluating the safety and efficacy of G/P across all major HCV genotypes (genotypes 1-6) at an upcoming scientific congress.


in like manner streetinsider

Pibrentasvir HCV Regiment Receives FDA Breakthrough Therapy Designation

Pibrentasvir HCV Regiment Receives FDA Breakthrough Therapy Designation

AbbVie (NYSE: ABBV) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including therapy with an NS5A inhibitor and/or protease inhibitor.The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study.According to the FDA, BTD is intended to expedite the development and review of therapies for serious or life threatening conditions.1"AbbVie is committed to advancing HCV care and addressing areas of continued unmet need for people living with chronic HCV," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie.


not to mention businesswire

Enanta Pharmaceuticals Announces AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

Enanta Pharmaceuticals Announces AbbVie's Investigational HCV Regimen Receives U.S. FDA Breakthrough Therapy Designation

WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc., (NASDAQ: ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for AbbVie's investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1 (GT1), including previous therapy with an NS5A inhibitor and/or protease inhibitor.The BTD is supported by positive results seen in AbbVie's Phase 2 MAGELLAN-1 clinical study.According to the FDA, BTD is intended to expedite the development and review of an investigational therapy for a serious or life threatening condition when there is preliminary clinical evidence that the therapy may demonstrate substantial improvement over any existing therapy.1"The FDA's Breakthrough Therapy Designation is an important step for AbbVie's efforts to bring to market its pan-genotypic HCV medicine containing our second-generation protease inhibitor," stated Jay R. Luly, Ph.D., CEO of Enanta.