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FDA Accepts NDA for Review of 3D Regimen

AbbVie announced that the FDA has accepted its New Drug Application for review of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets taken once daily for the treatment of chronic hepatitis C virus infection, including those with compensated cirrhosis.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak, (AbbVie) can be used with or without ribavirin, but it is not recommended for patients with decompensated cirrhosis. The current recommended dosing regimen is ombitasvir, paritaprevir and ritonavir taken twice daily as three tablets in the morning and one tablet of dasabuvir in the evening, taken with a meal, according to the release. The proposed dosing for the fixed-dose formulation is combining dasabuvir so there are only three oral tablets taken once daily with a meal, with or without twice-daily RBV, instead of four daily.

“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,” Michael Severino, MD, executive vice president, research and development and chief scientific officer at AbbVie, said in the release. “This milestone further underscores AbbVie’s commitment to offer people living with hepatitis C optimized treatment options.”

In October, the FDA issued a report, warning that the fixed-dose combination could lead to severe liver injury and required AbbVie to update the drug label. In a previous interview, Barry Bernstein, MD, vice president, infectious disease development, AbbVie, told HCV Next that the label updates were “based on postmarketing reports” and the company was in compliance with the FDA’s requests.

The FDA first approved Viekira Pak for the treatment of HCV in December 2014.

Disclosures: Bernstein and Severino are employed by AbbVie.