FDA to Review New Once Daily Viekira Pak Formulation
AbbVie announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for a once-daily, fixed-dose formulation of the components of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.
The NDA submission is supported by data from two bioavailability studies. The current dosing for Viekira Pak is twice daily (3 tablets in the morning and 1 tablet in the evening) taken with a meal. The proposed new dosing for the fixed-dose formulation (dasabuvir, ombitasvir, paritaprevir, ritonavir tablets) is 3 tablets once daily with a meal, with or without twice daily ribavirin (RBV).
Viekira Pak, an all-oral, interferon-free treatment approved with or without RBV, consists of the fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), ritonavir 100mg (an HIV-1 protease inhibitor), and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor).
For more information call (800) 633-9110 or visit AbbVie.com.