Application for New Once-Daily Viekira Pak Formulation Accepted by FDA


FDA decision expected in second half of 2016.

FDA decision expected in second half of 2016.

A more convenient formulation of a leading hepatitis C drug may reach the hands of patients at some point next year.

AbbVie announced Wednesday that the FDA accepted its New Drug Application (NDA) for a once-daily, fixed-dose formulation of Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets). The drug combination is currently administered twice daily with 3 tablets in the morning and another tablet in the evening, which are taken with a meal.

The all-oral, interferon-free treatment was previously approved with or without ribavirin for genotype 1 chronic hepatitis C virus infection, including the treatment of compensated cirrhosis, but not decompensated cirrhosis.

The new formulation of Viekira Pak includes dasabuvir, ombitasvir, paritaprevir and ritonavir tablets taken as 3 oral tablets once daily with a meal, with or without twice-daily ribavirin. The NDA followed data from a pair of bioavailability studies.

"Nearly 1 year after the launch of Viekira Pak, AbbVie is pleased to announce the acceptance of a New Drug Application for a once-daily formulation for the treatment of patients with chronic genotype 1 hepatitis C," said Michael Severino, MD, executive vice president, research and development and chief scientific officer at AbbVie. "This milestone further underscores AbbVie's commitment to offer people living with hepatitis C optimized treatment options."

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