AbbVie submits NDA to US FDA for pan-genotypic regimen of G/P
Global biopharmaceutical company AbbVie has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its investigational, pan-genotypic regimen of glecaprevir / pibrentasvir (G/P).
The company is evaluating G/P for the treatment of chronic hepatitis C virus (HCV).
Eight weeks of therapy with G/P during Phase III clinical studies achieved sustained virologic response (SVR) rates across all major genotypes (GT 1-6) in patients without cirrhosis.
High SVR rates were achieved in patients with compensated cirrhosis after 12 weeks of therapy and also in patients with limited treatment options, such as those who had severe chronic kidney disease (CKD).
AbbVie research and development and chief scientific officer executive vice-president Michael Severino said: "Our regimen of glecaprevir and pibrentasvir shows promise for patients by achieving high cure rates in Phase III clinical studies across all major hepatitis C genotypes.
"We look forward to working with the FDA as they review our new drug application, which we believe represents another important step toward a faster path to virologic cure for hepatitis C patients."
The company’s application is supported by data from eight registrational studies in its G/P clinical development programme.
More than 2,300 patients were evaluated in 27 countries across major HCV genotypes and special populations as part of this programme.
AbbVie announced in September this year that it obtained breakthrough therapy designation (BTD) from the FDA for G/P for the treatment of patients with HCV who were not cured with prior DAA therapy in genotype 1 (GT1).
The company’s G/P clinical development programme has been designed to investigate a path to virologic cure for all major HCV genotypes (GT1-6).