Obeticholic Acid: First Global Approval

Drugs

Volumn 76, Issue 12, 2016, Pages 1221-1226

  Markham, A ^a   Keam, Susan J ^a  

^a SPRINGER   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

OBETICHOLIC ACID; CHENODEOXYCHOLIC ACID; URSODEOXYCHOLIC ACID;

ABDOMINAL PAIN; ARTHRALGIA; ARTICLE; ASCITES; BILE DUCT ATRESIA; CHOLANGITIS; CHRONIC BILE ACID DIARRHEA; CONSTIPATION; DIARRHEA; DIZZINESS; DRUG ABSORPTION; DRUG APPROVAL; ECZEMA; FATIGUE; FEVER; HEART PALPITATION; HEPATIC ENCEPHALOPATHY; HEPATITIS; HUMAN; MAXIMUM PLASMA CONCENTRATION; NONALCOHOLIC FATTY LIVER; OROPHARYNX PAIN; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIMARY BILIARY CHOLANGITIS; PRIMARY SCLEROSING CHOLANGITIS; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; SLEEP DISORDER; TIME TO MAXIMUM PLASMA CONCENTRATION; ANALOGS AND DERIVATIVES; LIVER CIRRHOSIS, BILIARY; PROCEDURES;

CHENODEOXYCHOLIC ACID; DRUG APPROVAL; HUMANS; LIVER CIRRHOSIS, BILIARY; URSODEOXYCHOLIC ACID;

EID: 84978173289     PISSN: 00126667     EISSN: 11791950     Source Type: Journal    
DOI: 10.1007/s40265-016-0616-x     Document Type: Article

References (15)

1. Intercept Pharmaceuticals. OCALIVA (obeticholic acid) US Prescribing Information. 2016. http://www.interconnectsupport.com/ocaliva_pi.pdf. Accessed 31 May 2016.
2. Mudaliar S, Henry RR, Sanyal AJ, et al. Efficacy and safety of the farnesoid X receptor agonist obeticholic acid in patients with type 2 diabetes and nonalcoholic fatty liver disease. Gastroenterology. 2013;145(3):574–82.
3. Dainippon Sumitomo Pharma Co L, Intercept Pharmaceuticals I. Dainippon Sumitomo Pharma and Intercept Pharmaceuticals announce agreement to develop and commercialize obeticholic acid (INT-747) for chronic liver disease [media release]. 30 Mar 2011. http://www.interceptpharma.com.
4. Intercept Pharmaceuticals Inc. Intercept Pharmaceuticals submits applications in the U.S. and Europe for marketing approval of obeticholic acid for the treatment of primary biliary cirrhosis [media release]. Jun 29 2015. http://ir.interceptpharma.com/releasedetail.cfm?releaseid=919926.
5. US Food and Drug Administration. FDA approves Ocaliva for rare, chronic liver disease [media release]. May 31 2016. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503964.htm.
6. Neuschwander-Tetri BA, Loomba R, Sanyal AJ, et al. Farnesoid X nuclear receptor ligand obeticholic acid for non-cirrhotic, non-alcoholic steatohepatitis (FLINT): a multicentre, randomised, placebo-controlled trial. Lancet. 2015;385:956–65.
7. Pellicciari R, Fiorucci S, Camaioni E, et al. 6alpha-ethyl-chenodeoxycholic acid (6-ECDCA), a potent and selective FXR agonist endowed with anticholestatic activity. J Med Chem. 2002;45(17):3569–72.
8. Albanis E, Alvarez CE, Pruzansky M, et al. INT-747, a novel FXR activator, reverses hepatic fibrosis and cirrhosis in thioacetamide-induced liver injury in rats [abstract no. 1040]. Hepatology. 2005;42(Suppl 1):605–6.
9. Verbeke LD, Mannaerts I, Schierwagen R, et al. Obeticholic acid, an FXR agonist, reduces hepatic fibrosis in a rat model of toxic cirrhosis [abstract no. P0445]. J Hepatol. 2015;62(Suppl 2):S479.
10. Nevens F, Andreone P, Mazzella G, et al. An international phase 3 study of the FXR agonist obeticholic acid in PBC patients: effects on markers of cholestasis associated with clinical outcomes and hepatocellular damage [abstract no. 295]. Hepatology. 2014;60(Suppl 4):347A–8A.
11. Trauner MH, Nevens F, Andreone P, et al. Durable response in the markers of cholestasis through 18 months of open-label long term safety extension study of obeticholic acid in primary biliary cirrhosis [abstract no. Sa1579]. Gastroenterology. 2016;150(4 Suppl 1):S1073–4.
12. Hirschfield GM, Mason A, Luketic V, et al. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015;148(4):751–61.
13. Kowdley KV, Shah H, Mason A, et al. Long-term safety and efficacy of obeticholic acid treatment in primary biliary cirrhosis after more than 4 years of treatment [abstract no. 628]. Hepatology. 2015;62(Suppl 1):521A–2A.
14. Walters JR, Johnston IM, Nolan JD, et al. The response of patients with bile acid diarrhoea to the farnesoid X receptor agonist obeticholic acid. Aliment Pharmacol Ther. 2015;41(1):54–64.
15. Ratziu V, Sanyal AJ, MacConell L, et al. Regenerate: a phase 3, double-blind, randomized, placebo-controlled multicenter study of obeticholic acid therapy for nonalcoholic steatohepatitis [abstract no. THU-488]. J Hepatol. 2016;64(Suppl 2):S294–5.