ABT 493 (glecaprevir) plus ABT 530 (pibrentasvir) filed with FDA for chronic HCV- Enanta/AbbVie

Enanta Pharmaceuticals announced that AbbVie has submitted a New Drug Application (NDA) to the U.S. FDA for its investigational, pan-genotypic, fixed-dose combination of ABT 493 (glecaprevir) and ABT 530 (pibrentasvir) (G/P), being evaluated for the treatment of chronic HCV. In Phase III clinical studies, eight weeks of therapy with G/P demonstrated high sustained virologic response (SVR) rates across all major genotypes (GT1-6) in patients without cirrhosis and who are new to treatment, which represent the majority of HCV patients. In patients with compensated cirrhosis, high SVR rates were achieved after 12 weeks of therapy. High SVR rates were also achieved in patients with limited treatment options, such as those with severe chronic kidney disease (CKD). In historically difficult to treat populations, including those not cured by prior direct-acting antiviral (DAA) treatment regimens, high rates of SVR were achieved with durations as short as 12 weeks.

The NDA is supported by data from eight registrational studies in AbbVie's G/P clinical development program, which evaluated more than 2,300 patients in 27 countries across major HCV genotypes and special populations. Patient populations studied included all major genotypes, new and experienced to treatment, those with and without cirrhosis and patients with specific treatment challenges, including those with severe CKD, and those who have failed a DAA-containing regimen. AbbVie previously announced registrational data that show with eight weeks of treatment, 97.5 percent (n=693/711) of chronic HCV patients across all major genotypes (GT1-6) without cirrhosis and new to treatment achieved SVR12. Additional data submitted show that with 12 weeks of treatment, 98 percent (n=102/104) of severe CKD patients achieved SVR12 in a primary intent-to-treat (ITT) analysis.

Comment: AbbVie has announced it is on track to submit a marketing authorization application for G/P in the European Union in early 2017.