|Enanta Pharmaceutical's review slated for late December|
|By Dr. Amna Sheikh|
|Tuesday, 11 November 2014 11:27|
Enanta Pharmaceutical, Inc, (NASDAQ:ENTA) recently announced that their collaborator Abbvie’s New Drug Application for an interferon-free regimen had been acknowledged by U.S. Food and Drug Administration. The NDA for acceptance of this regimen was submitted on April 21, 2014. The BioMedReports FDA Calendar shows a date for review on December 21, 2014.This all-oral interferon free regiment has been developed for treatment of interminable genotype 1 hepatitis C virus. Enanta Pharmaceuticals is known as one of the leading research and development companies concentrating in biotechnology for development of small molecule drugs used for treatment of infectious diseases.
What is antiviral investigational regimen?
The hepatitis C virus causes a liver infection known as Hepatitis C. The disease can turn into chronic infection with variation of severity from a mild sickness just for few weeks or turn out to be serious lifetime illness. The interferon-free regimen is a blend of ABT-450 (NS3 protease inhibitor) or Ritonavir (150/100mg) combined with 25 mg of Ombitasvir (ABT-267) and 250mg of Dasabuvir (ABT-333). Protease inhibitors play an essential role in the viral life cycle of the hepatitis C virus (HCV). It has been seen that the protease inhibition prevents synthesis of those proteins which are non-structural (NS) and thereby prevents replication and survival of the HCV virus.
The HCV patients should utilize a dosage of ABT-450 together with Ombitasvir once in a day. Moreover, they should take Dasabuvir 250 mg twice a day. Enanta with mutual collaboration of AbbVie holds an accolade of developing ABT-450 as one of the leading protease inhibitor.
What is Hepatitis C Virus (HCV)?
HCV is a blood borne virus and the major widespread means of contagion include perilous injection practices; poor sterilization of medicinal utensils in several health-care units; as well as unsafe contact with infected blood serum. In case of chronic Hepatitis C, it can lead to liver scarring and causes cirrhosis. However, in many known cases; the cirrhosis is diagnosed in last stages. And many patients suffering with cirrhosis develop liver cancer or liver failure and in some severe cases, acute gastric varices or esophageal.
The most common causes for spread of HCV include unsafe blood contact due to intravenous drug utilization, transfusion or by use of contaminated medical equipment. According to World Health Organization, almost about 50 million people around the world are suffering with acute hepatitis C virus and a large number of these patients develop liver cancer or cirrhosis in later stages. According to the WHO, about half a million people die each year due to HCV. Previously, the HCV infection is treated with a combination therapy of ribavirin and peginterferon with either telaprevir or boceprevir. Recovery rate among patients was recorded as fifty to eighty percent of total treated patients.
About Enanta Pharmaceutical, Inc
In the world of pharmaceutics, Enanta Pharmaceutical is well known for its research and development activities concerted towards biotechnology. They are producing molecule drugs through strong chemistry determined approach together with drug invention capabilities for treatment of infectious diseases. Currently, they are busy in development of new inhibitors intended for application against the acute virus of hepatitis C or HCV. These inhibitors are comprised of members from the NS5A, DAA and nucleotide polymerase. Moreover, it also includes an HTA or host targeted antiviral inhibitor class for operation against cyclophilin. Currently, the operations of Enanta are controlled and monitored from Watertown, Massachusetts.