The first Nash drug in the world! Ocaliva (OCA, OBC) has entered the priority review in the United States and will be approved for listing in the first quarter of 2020!

November 29, 2019 / BIOON / -- intercept Pharma is a biopharmaceutical company focusing on the development and commercialization of new therapies for the treatment of progressive, non viral liver diseases Recently, the company announced that the U.S Food and Drug Administration (FDA) has accepted a new drug application (NDA) submitted by it and granted priority review The NDA applied for accelerated approval of ocaliva (obeticolic acid, OCA, OBC) in the treatment of non-alcoholic steatohepatitis (NASH) induced fibrosis FDA gives priority to drugs that have the potential to treat serious diseases, and if approved, will provide significant progress in safety or effectiveness FDA has designated the target date of prescription drug user fee Act (PDUFA) for this NDA as March 26, 2020 In the NDA acceptance notice, FDA said that it plans to hold an advisory committee meeting at present to discuss the application of talon The date of the Advisory Committee meeting has not yet been finalized, and FDA's review schedule for the NDA is likely to change It is worth mentioning that in NASH, ocaliva is the only research drug granted breakthrough drug qualification (BTD) by FDA, and it is the first research drug to enter and successfully complete phase III clinical trials in the world Mark pruzanski, President and CEO of intercept, said: "if approved, OCA will be the first method available to treat patients with liver fibrosis caused by Nash, which is expected to become the main cause of liver transplantation in the United States as soon as 2020 This NDA acceptance is a key regulatory milestone that brings us closer to our goal of providing patients with this devastating disease with the first regulatory approved treatment From the breakthrough drug qualification previously granted by OCA to the priority review qualification granted today, our cooperation with FDA continues to set an important precedent in this field, and we look forward to working closely with FDA in the NDA review process in the next few months " The NDA was based on positive interim analysis of the critical phase III regenerate study The study was carried out in patients with stage 2 or stage 3 liver fibrosis due to Nash and evaluated the efficacy and safety of two doses of OCA (10mg and 25mg once a day) compared with placebo In the primary efficacy analysis, at the pre planned mid-term analysis of 18 months, the primary end point of fibrosis improvement (≥ 1 stage) and no deterioration of Nash was achieved at a dose of 25mg 0ca once a day compared with placebo (P = 0.0002) In addition, a higher proportion of patients in the 25 mg OCA group achieved the primary end point of Nash elimination and no deterioration of liver fibrosis compared with the placebo group Octalva is a farneside X receptor (FXR) agonist, which is a nuclear receptor expressed in liver and small intestine, and a key regulator in bile acid, inflammation, fibrosis and metabolic pathways In the United States, ocaliva was approved for marketing in May 2016 for the treatment of primary biliary cholangitis (PBC) At present, ocaliva is being developed for the treatment of many other chronic liver diseases, including Nash, primary sclerosing cholangitis, biliary atresia, etc Nonalcoholic steatohepatitis (NASH) is a kind of serious progressive liver disease Chronic inflammation caused by excessive accumulation of liver fat leads to progressive fibrosis (scar), which can lead to cirrhosis, liver failure, liver cancer and death Late fibrosis is associated with a marked increase in liver incidence rate and mortality in NASH patients According to nature, Nash has become the second most common cause of liver transplantation after chronic hepatitis C in the United States and is expected to be the leading cause in 2020 At present, the market size of Nash has reached US $40 billion However, despite the urgent medical needs, so far no drug has been approved for NASH treatment Original source: FDA accepts intercept's NDA for OCA for the treatment of liver fibrosis due to Nash and grants priority review