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Pan-Genotypic HCV Regimen Gets Breakthrough Status

Pan-Genotypic HCV Regimen Gets Breakthrough Status

AbbVie announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the pan-genotypic regimen of glecaprevir/pibrentasvir (ABT-493/ABT-530) for the treatment of patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals (DAAs) in genotype 1, including therapy with an NS5A inhibitor and/or protease inhibitor.

The Breakthrough Therapy designation was based on data from the Phase 2 MAGELLAN-1 clinical study. The designation allows for expedited development and review of therapies for serious or life-threatening conditions.

The clinical development program is designed to investigate a pan-genotypic (genotypes 1 to 6) regimen of glecaprevir/pibrentasvir, which is currently in Phase 3 clinical development. The regimen includes glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor. It is dosed once daily as three oral tablets.

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