AbbVie’s hepatitis C treatment under FDA priority review

The priority review status will reduce the review clock to six months from the standard 10 months. Even though the action date is not specified, it is expected to happen this summer.

AbbVie's marketing application in Europe was recently accepted ago under accelerated review.

The company’s NDA is backed by results collected from eight studies conducted on more than 2,300 patients in 27 countries.

AbbVie executive vice president, research and development and chief scientific officer Michael Severino said: “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.”

G/P regimen combines two antiviral agents in a fixed-dose combination of glecaprevir (300mg), an NS3/4A protease inhibitor, and pibrentasvir (120mg), an NS5A inhibitor. It is dosed once-daily as three oral tablets.

It is being assessed as a potential cure in 8 weeks for HCV patients without cirrhosis and who are new to treatment, that make up the majority of HCV patients.

AbbVie is also assessing G/P in patients with particular treatment challenges, like genotype 3, patients who were not cured with previous DAA treatment and those with CKD, including patients on dialysis.

The drug regimen succeeded in a phase 3 clinical trial, which showed treatment with G/P delivered a 98% (n=102/104) cure rate (SVR12) after 12 weeks of treatment.

In a modified intent-to-treat analysis, excluding subjects who did not achieve SVR for reasons other than virologic failure, the cure rate was 100% (n=102/102).

Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.