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# FDA Gives Breakthrough Status to AbbVie Hep C Therapy
- URL: https://www.fdaweb.com/fda-gives-breakthrough-status-to-abbvie-hep-c-therapy/
- Published: 2016-09-30T12:00:00.000Z
- Updated: 2026-09-14T21:36:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136957

FDA has granted AbbVie a breakthrough therapy designation for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for treating patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor or protease inhibitor. The designation is supported by positive results from the company’s Phase 2 MAGELLAN-1 clinical study. The combination therapy was discovered during an ongoing collaboration between AbbVie and Enanta Pharmaceuticals for HCV protease inhibitors and regimens that include protease inhibitors.