FDA News

FDA grants priority review for AbbVie's pan-genotypic HCV regimen

The FDA has accepted AbbVie’s New Drug Application for glecaprevir/pibrentasvir and granted it priority review, the company announced.

Glecaprevir/pibrentasvir is an investigational regimen under evaluation as a possible 8-week cure for non-cirrhotic patients with all major genotypes of hepatitis C virus infection who have not received prior treatment, according to a press release.

The regimen combines two antiviral agents — 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor — that are administered once daily in three oral tablets.

Data from eight registrational studies involving more than 2,300 patients from 27 countries support the NDA, which AbbVie submitted in December. These studies evaluated all major HCV genotypes, treatment-experienced and -naive patients, those with and without cirrhosis, those who were not cured with a previous direct-acting antiviral containing regimen, and those with treatment challenges like severe chronic kidney disease.

“We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the press release.

The FDA designates priority review status to drugs that show potential for significantly improving the safety and effectiveness of the treatment of a serious disease.

Disclosures: Severino is employed by AbbVie.

The FDA has accepted AbbVie’s New Drug Application for glecaprevir/pibrentasvir and granted it priority review, the company announced.

Glecaprevir/pibrentasvir is an investigational regimen under evaluation as a possible 8-week cure for non-cirrhotic patients with all major genotypes of hepatitis C virus infection who have not received prior treatment, according to a press release.

The regimen combines two antiviral agents — 300 mg of glecaprevir, an NS3/4A protease inhibitor, and 120 mg of pibrentasvir, an NS5A inhibitor — that are administered once daily in three oral tablets.

Data from eight registrational studies involving more than 2,300 patients from 27 countries support the NDA, which AbbVie submitted in December. These studies evaluated all major HCV genotypes, treatment-experienced and -naive patients, those with and without cirrhosis, those who were not cured with a previous direct-acting antiviral containing regimen, and those with treatment challenges like severe chronic kidney disease.

“We will continue to work closely with the agency as they review our New Drug Application and we remain committed to bringing a new cure to patients with chronic hepatitis C,” Michael Severino, MD, executive vice president of research and development and chief scientific officer at AbbVie, said in the press release.

The FDA designates priority review status to drugs that show potential for significantly improving the safety and effectiveness of the treatment of a serious disease.

Disclosures: Severino is employed by AbbVie.