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.

"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."

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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).