The world's first NASH drug! Ocaliva (OCA, Obergecacid) was delayed for the third time in the U.S. review, and Intercept's lead remained unchanged!

May 25, 2020 /
PRNewswire
BIOON/ -- Intercept Pharma is a biopharmaceutical company focused on the development and commercialization of new therapeutic strains for progressive, non-viral liver diseaseThe company recently announced that the U.SFood and Drug Administration (
FDA) had informed the company that itsmeeting, tentatively scheduled for June 9, 2020, had been postponedon the company's drug Ocaliva (OCA, Oca, Obercacid) for the treatment of non-alcoholic fatty hepatitis (NASH) for new drug fibrosis (NDA)Intercept's shares plunged 15 percent after the newsthe delay was due to the FDA's need to review additional data, which the company plans to submit this weekThe FDA has said it will set a new AdCom date soonIntercept nowexpects the FDA'sreview of ndA to exceed the Target Action Date of June 26, 2020, for the Prescription Drug User Charges Act (PDUFA)by the end of November 2019, the FDA accepted Ocaliva's NDA and granted priority reviewsThe NDA applied for accelerated approval of Ocaliva for treatment of fibrosis caused by non-alcoholic fatty hepatitis (NASH)At the time, theFDAhad designated a PDUFA target date of March 26, 2020it is worth noting that this delay is not the first timeIn fact, it has been postponed twice beforeThe first was in mid-December 2019, when Intercept announced that the FDA had notified the company that it had postponed the AdCom meeting until April 22, 2020, and that the PDUFA target date would be extended accordinglyThe second was in late March 2020, when Intercept again announced that theFDApostpone the AdCom meeting until June 9 because of the new coronavirus pneumonia (COVID-19) outbreakThe latest delay is also the thirdnearly two years, many of NASH's progressive rivals have suffered setbacks, including Gilead Sciences, so Intercept's lead has not changedThe latest delay will not give other competitors the upper handin the United States, NASH is expected to be the leading cause of liver transplants as soon as 2020if approved, Ocaliva would be the first to be used to treat patients with NASH-induced liver fibrosisespecially noteworthy, ocA is the onlyin NASH The FDA the research drug that grants breakthrough drug eligibility (BTD) and is the first research drug in the world to successfully complete Phase III clinically December 2019, positive results from a mid-term analysis of phase III RE GENERATE study evaluating ocaliva (obeticholic acid, OCA, Obebicacid) for the treatment of fibrosis caused by non-alcoholic fatty hepatitis (NASH) were published in The Lancet This is also the first peer review to evaluate positive results from a key clinical study of the research drug NASH the study was conducted in patients with stage 2 or 3 liver fibrosis due to NASH, and the efficacy and safety of two doses of OCA (10 mg and 25 mg, once daily) were assessed relative to placebo in the main efficacy analysis, in a pre-planned 18-month mid-period analysis, a daily dose of 25 mg 0CA achieved a fibrosis improvement (1 stage) and nash did not deteriorate the primary endpoint (p.0.0002) compared to placebo In addition, a higher proportion of patients in the 25 mg dose OCA treatment group reached the primary endpoint of NASH elimination and no deterioration of liver fibrosis than in the placebo group "The first positive Phase III study in nash represents a real watershed in this field of hepatology," said Zobair M Younossi, a professor and dean of the department of medicine at the Fairfax Medical School in , and the chair of the REGENERATE Steering Committee The antifibrosis observed after 18 months of OCA treatment in the REGENERATE study was particularly significant because fibrosis was the most important histological predictor of liver failure and death in NASH patients "
Ocaliva is a faniester X receptor (FXR) agonist, a nuclear receptor expressed in the liver and small intestine and a key regulator in bile acid, inflammation, fibrosis, and metabolic pathways In the United States, Ocaliva was approved for the treatment of primary bile bile bile ductitis (PBC) in May 2016 Currently, Ocaliva is being developed for the treatment of a variety of other chronic liver diseases, including NASH, primary sclerosing bile ductitis, bile duct alkare, etc non-alcoholic fatty hepatitis (NASH) is a severe progressive liver disease that causes chronic inflammation caused by excessive accumulation of liver fat, leading to progressive fibrosis (scarring), which can lead to cirrhosis, liver failure, liver cancer and death Late fibrosis was associated with significant increases in liver-related morbidity and mortality in NASH patients In the United States, NASH has become the second most common cause of liver transplantation after chronic hepatitis C, and is expected to be the leading cause by 2020, according to nature The NASH market is now $40 billion However, despite urgent medical needs, no drugs have been approved to treat NASH so far (biovalleybioon.com) original source: Intercept shares fall as FDA
stime swatchwatched NASH drug