Enanta Pharmaceuticals, Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted AbbVie’s 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. The priority designation shortens the regulatory review period from the standard 10 months to 6 months.
Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie collaboration and is one of the direct-acting antivirals in AbbVie’s VIEKIRA PAK treatment regimens for chronic hepatitis C virus (HCV).
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.
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).
The Centers for Disease Control and Prevention (CDC) estimates that in the United States, 2.7 million people are chronically infected with HCV.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 have GT1a HCV infection and 23 percent have GT1b.
