Enanta Pharma (ENTA) Affirms FDA Breakthrough Therapy Designation Given to AbbVie’s HCV Regimen

September 30, 2016 8:09 AM EDT

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Enanta Pharmaceuticals, Inc., (Nasdaq: ENTA) 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. “AbbVie is also investigating an eight-week regimen of G/P for the majority of patients. We look forward to release of additional clinical data on G/P in the coming months.”

Glecaprevir (GLE) is Enanta’s second protease inhibitor being developed through its collaboration with AbbVie. AbbVie’s investigational regimen includes GLE, an NS3/4A protease inhibitor, and pibrentasvir (PIB), an NS5A inhibitor, which are co-formulated and dosed once daily as three oral tablets.

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. There is additional information on the clinical trials for G/P conducted by AbbVie available at www.clinicaltrials.gov.

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