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FDA Grants Priority Review of Supplemental NDA for Viekira Pak

AbbVie announced that the FDA accepted its supplemental new drug application and granted priority review of Viekira Pak without ribavirin for the treatment of genotype 1b hepatitis C virus infection and compensated cirrhosis.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak, (AbbVie) can be used with or without ribavirin, but is not recommended for patients with decompensated cirrhosis.

The proposed dosing in the supplemental new drug application is to eliminate the use of ribavirin for this patient population. “The current dosing recommendation for patients with HCV [genotype 1b] and compensated cirrhosis is to administer Viekira Pak with ribavirin for 12 weeks,” according to the release.

The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

“We are pleased that the FDA has granted priority review for Viekira Pak without ribavirin as a therapy for treating [genotype 1b] chronic hepatitis C patients who have compensated cirrhosis,” Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, said in the release. “The filing of this [supplemental new drug application] further underscores AbbVie's commitment to patients living with chronic HCV infection.”

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

In October 2015, 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 Healio.com/Hepatology that the label updates were “based on postmarketing reports” and the company was in compliance with the FDA’s requests.

The FDA accepted AbbVie’s new drug application for review of Viekira Pak in December 2015.

Disclosure: Severino is employed by AbbVie.

AbbVie announced that the FDA accepted its supplemental new drug application and granted priority review of Viekira Pak without ribavirin for the treatment of genotype 1b hepatitis C virus infection and compensated cirrhosis.

A combination of ombitasvir, paritaprevir and ritonavir tablets with dasabuvir tablets, Viekira Pak, (AbbVie) can be used with or without ribavirin, but is not recommended for patients with decompensated cirrhosis.

The proposed dosing in the supplemental new drug application is to eliminate the use of ribavirin for this patient population. “The current dosing recommendation for patients with HCV [genotype 1b] and compensated cirrhosis is to administer Viekira Pak with ribavirin for 12 weeks,” according to the release.

The FDA grants priority review designation to investigational therapies that treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.

“We are pleased that the FDA has granted priority review for Viekira Pak without ribavirin as a therapy for treating [genotype 1b] chronic hepatitis C patients who have compensated cirrhosis,” Michael Severino, MD, executive vice president, research and development and chief scientific officer of AbbVie, said in the release. “The filing of this [supplemental new drug application] further underscores AbbVie's commitment to patients living with chronic HCV infection.”

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

In October 2015, 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 Healio.com/Hepatology that the label updates were “based on postmarketing reports” and the company was in compliance with the FDA’s requests.

The FDA accepted AbbVie’s new drug application for review of Viekira Pak in December 2015.

Disclosure: Severino is employed by AbbVie.