On Monday, Shares of Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) gained 0.41% to $31.91. The share price is trading in a range of 31.60 - 32.49 (Price in Dollars). The stock exchanged hands with 159,253 shares contrast to its average daily volume of 284,741 shares. Enanta Pharmaceuticals, declared that the U.S. Food and Drug Administration (FDA) has approved AbbVie’s supplemental New Drug Application (sNDA) for the use of VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) infection and compensated cirrhosis (Child-Pugh A). The application was formerly granted priority review by the FDA, a designation given to investigational therapies that treat a serious condition and provide a noteworthyimprovement in safety or effectiveness.
Paritaprevir is Enanta’s lead protease inhibitor identified within the ongoing Enanta-AbbVie partnership and is one of the direct-acting antivirals in AbbVie’s VIEKIRA PAK®.
VIEKIRA PAK is a prescription medicine used with or without RBV (depending on the sub-genotype of the patient’s HCV infection and other factors) to treat adults with genotype 1 (GT1) chronic (lasting a long time) HCV infection, counting people who have a certain type of cirrhosis (compensated). VIEKIRA PAK is not for people with more advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking VIEKIRA PAK.
During the most recent trading day, the stock’s price shifted up 90.51 percent from its 52-week-low while 38.50 percent lower from its 52-week high. The stock’s price moved down its 200 day moving average of $30.01. The stock is presently trading up its SMA 50 of $29.40. The Centers for Disease Control and Prevention estimates that in the United States, about 2.7 million people are chronically infected with HCV. Genotype 1 is the most common HCV in the U.S.2 Of the total U.S. population with GT1 HCV infection, about 77 percent are genotype 1a (GT1a) and 23 percent are GT1b.
The share price of Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA) declined 14.08 percent for the year. YTD, the current share price of the stock is below 3.36 percent. The company holds earnings per share (EPS) of $3.28 for the twelve months. 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). Patients who achieve SVR12 are considered cured of HCV, as the virus is no longer detectable in the blood. No patients suspended treatment because of adverse events. The most commonly-stated 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).
On February 26, AbbVie declared that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) and this RBV-free option is now approved for use for the treatment of chronic HCV infected GT1b patients with compensated cirrhosis (Child-Pugh A) in Europe.
