AbbVie Inc. submitted a new drug application to the U.S. FDA seeking approval of glecaprevir/pibrentasvir for the treatment of chronic hepatitis C virus.
Glecaprevir/pibrentasvir combines two different antiviral agents in a fixed-dose combination of glecaprevir and pibrentasvir.
Phase 3 clinical studies showed that eight weeks of therapy with the drug achieved high sustained virologic response rates across all major genotypes in patients without cirrhosis, which represents the majority of hepatitis C patients.
The application is supported by data from eight registrational studies in the company's clinical development program.
If approved, glecaprevir/pibrentasvir will provide an eight week once-daily, ribavirin-free treatment option for patients without cirrhosis across all major genotypes.
The drug received a breakthrough therapy designation from the FDA on Sep. 30, for the treatment of patients who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor or protease inhibitor.
The company expects to file a marketing application in the EU in early 2017.
Glecaprevir is being developed through collaboration between AbbVie and Enanta Pharmaceuticals Inc.