Get ready! First NASH drug to be launched Triples Intercept sales force

Non-alcoholic fatty hepatitis (NASH) is an extreme developmental form of non-alcoholic fatty liver disease, defined as the appearance of fatty degeneration accompanied by inflammation and liver cell damageNASH can lead to late-stage liver fibrosis, cirrhosis, liver failure, and the production of liver tumorsAccording to nature, NASH has become the second most common cause of liver transplantation in the United States after chronic hepatitis C and is expected to be the number one cause in 2020The NASH market is now $40 billionHowever, despite the urgent medical needs, no drugs have been approved for NASH treatment so far, the developer of Ocaliva, the only NASH drug currently in the regulatory review process, is actively preparing for a potential commercial launchIts chief operating officer, Jerry Durso, said last week that the company had made significant progress in preparing for the launch of Ocaliva Treatment NASHThe company has initiated payer negotiations, formed an internal sales force, and is working with a contract sales team, which will provide the company with additional opportunities and flexibilityOcaliva is a faniester X receptor (FXR) agonist, which was approved for use in the united states in May 2016 for the treatment of primary bile bile bile cholositis (PBC)Currently, Ocaliva is developing treatments for a variety of other chronic liver diseases, including NASH, primary sclerosing bile ductitis, bile duct altiming, etcit's worth noting that in NASH, Ocaliva is the only research drug that has been qualified by the FDA for breakthrough drugs, and the first research drug in the world to successfully complete Phase III clinicallyin September, Intercept submitted to the FDA an application for a new drug (NDA) for Ocaliva's treatment of NASHIntercept has called for a priority review of ndA due to previously granted breakthrough drug eligibilityIf passed, the NDA's review period will be six monthsThat said, Ocaliva is likely to reap the FDA's review decision in the first half of next yearIn the EU, Intercept plans to submit a marketing authorization application for Ocaliva therapeutic NASH to the European Medicines Agency in the fourth quarterOf Ocaliva's NASH indication approval will be concentrated in patients with liver fibrosis Currently, patients with advanced liver fibrosis have no treatment options and there is an urgent need for effective treatment to prevent the development of cirrhosis in September, Intercept launched NASHTRUTH.com, an online educational resource for patients with advanced fibrosis caused by NASH, to enable patients to have a more productive conversation with healthcare providers about their illness At present, the payer also recognizes the need for NASH treatment With the help of the FDA, Intercept has begun active discussions with payers based on Phase III clinical data actively preparing, Intercept also released up-to-date data on non-invasive disease monitoring of NASH patients The latest analysis of phase III studies presented at the 2019 annual meeting of the American Association for The Study of Liver Disease showed that patients in the Ocaliva treatment group showed improvements in time and dose dependence using commercially available non-invasive testing methods compared to the placebo group These results suggest that these non-invasive tests can be used to monitor patients' responses to Ocaliva treatment, providing an advantage over liver biopsies in addition, , the patient report results (PRO) published at the meeting showed that although the itching levels in the Ocaliva 10mg and 25mg groups showed an increase dystosms, the peak severity of itching was observed early in the treatment process and did not deteriorate, and itching was generally relatively light and had no detectable negative effecton on PRO, indicating that the patient experience was not significantly affected reference sources: 1, Intercept aims to triple sales force as it gears up for potential NASH launch 2, NASH new drug market who will be the first to land? At a glance at the latest research and development progress