FDA Okays AbbVie's Viekira Pak To Treat Hepatitis C

(RTTNews) - AbbVie Inc (ABBV) on Friday said the U.S. Food and Drug Administration has approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to reduced liver function, liver failure or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV, and without proper treatment, 15 to 30 percent of these people will go on to develop cirrhosis.

Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that work together to inhibit the growth of hepatitis C virus (HCV). It also contains ritonavir, a previously approved drug used to increase blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver is unable to function properly (decompensated cirrhosis).

Viekira Pak is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

Viekira Pak's efficacy was evaluated in six clinical trials enrolling 2,308 participants with chronic HCV infection with and without cirrhosis. In different trials, participants were randomly assigned to receive Viekira Pak or placebo; Viekira Pak with or without ribavirin; or Viekira Pak with ribavirin for 12 or 24 weeks.

Results from multiple populations, including those considered difficult to treat, showed 91 to 100 percent of participants who received Viekira Pak at the recommended dosing achieved sustained virologic response.

Viekira Pak was reviewed under the FDA's priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

The U.S. approval of Viekira Pak triggers a $75 million regulatory approval milestone payment to Enanta Pharmaceuticals Inc (ENTA) from AbbVie. Viekira Pak regimen contains paritaprevir, which is Enanta's lead protease inhibitor.

Viekira Pak is the fourth drug product approved by the FDA in the past year to treat chronic HCV infection. The FDA approved Olysio (simeprevir) in November 2013, Sovaldi (sofosbuvir) in December 2013 and Harvoni (ledipasvir and sofosbuvir) in October 2014.