U.S. FDA Grants Priority Review to AbbVie for Supplemental New Drug Application for VIEKIRA PAK® (ombitasvir, paritaprevir, ritonavir tablets; dasabuvir tablets) without Ribavirin in Genotype 1b Chronic Hepatitis C Virus Patients with Compensated Cirrhosis
- The priority designation shortens the regulatory review period from the standard 10 months to six months
- TURQUOISE-III study showed 100 percent sustained virologic response at 12 weeks post-treatment (SVR12) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A
NORTH CHICAGO, Ill., Jan. 7, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) and granted priority review for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A). The current dosing recommendation for patients with GT1b and compensated cirrhosis is to administer RBV with VIEKIRA PAK for 12 weeks. 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.
VIEKIRA PAK is a prescription medicine used with or without ribavirin to treat adults with genotype 1 (GT1) chronic HCV infection, including people who have a certain type of cirrhosis (compensated). VIEKIRA PAK is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA PAK.
"We are pleased that the FDA has granted priority review for VIEKIRA PAK without ribavirin as a therapy for treating GT1b chronic hepatitis C patients who have compensated cirrhosis," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "The filing of this sNDA further underscores AbbVie's commitment to patients living with chronic HCV infection."
The TURQUOISE-III study included in the sNDA evaluated the use of VIEKIRA PAK without RBV for 12 weeks in GT1b patients with compensated cirrhosis (Child-Pugh A). Results demonstrated 100 percent (N=60/60) sustained virologic response at 12 weeks post-treatment (SVR12). No patients discontinued treatment due to adverse events. The most commonly-reported adverse events (≥10 percent) were fatigue (22 percent), diarrhea (20 percent), headache (18 percent), arthralgia (10 percent), dizziness (10 percent), insomnia (10 percent) and pruritus (10 percent).1
The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 2.7 million people are chronically infected with HCV.2 Genotype 1 is the most common HCV in the U.S.3 Of the total U.S. population with GT1 HCV infection, approximately 77 percent are genotype 1a (GT1a) and 23 percent are GT1b.3
About the TURQUOISE-III Study
TURQUOISE-III is a multi-center, open-label Phase 3b study to evaluate the safety and efficacy of 12 weeks of treatment with VIEKIRA PAK without ribavirin (RBV) in adult patients (N=60) with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated liver cirrhosis (Child-Pugh A) who were treatment-naïve or treatment-experienced (failed previous therapy with pegylated interferon and RBV). The primary endpoint is the rate of sustained virologic response 12 weeks after treatment (SVR12).1
About VIEKIRA PAK