Generic placeholder image

Current Drug Research Reviews

Editor-in-Chief

ISSN (Print): 2589-9775
ISSN (Online): 2589-9783

Review Article

Odevixibat: A Review of a Bioactive Compound for the Treatment of Pruritus Approved by the FDA

Author(s): Mayur Porwal*, Arvind Kumar, Vaibhav Rastogi, Kamal Kishore Maheshwari and Anurag Verma

Volume 16, Issue 1, 2024

Published on: 28 March, 2023

Page: [32 - 42] Pages: 11

DOI: 10.2174/2589977515666230308125238

Price: $65

Abstract

Odevixibat is synthesized through chemical modification of Benzothiazepine's structure. It is a tiny chemical that inhibits the ileal bile acid transporter and is used to treat a variety of cholestatic illnesses, including progressive familial intrahepatic cholestasis (PFIC). For cholestatic pruritus and liver disease development, bile acid transporter inhibition is a unique treatment strategy. Odevixibat reduces enteric bile acid reuptake. Oral odevixibat was also studied in children with cholestatic liver disease. Odevixibat received its first approval in the European Union (EU) in July 2021 for the treatment of PFIC in patients aged 6 months, followed by approval in the USA in August 2021 for the treatment of pruritus in PFIC patients aged 3 months. Bile acids in the distal ileum can be reabsorbed by the ileal sodium/bile acid cotransporter, a transport glycoprotein. Odevixibat is a sodium/bile acid co-transporter reversible inhibitor. An average 3 mg once-daily dose of odevixibat for a week resulted in a 56% reduction in the area under the curve of bile acid. A daily dose of 1.5 mg resulted in a 43% decrease in the area under the curve for bile id. Odevixibat is also being evaluated in many countries for the treatment of other cholestatic illnesses, including Alagille syndrome and biliary atresia. This article reviews the updated information on odevixibat with respect to its clinical pharmacology, mechanism of action, pharmacokinetics, pharmacodynamics, metabolism, drug-drug interactions, pre-clinical studies, and clinical trials.

Keywords: Odevixibat, intrahepatic cholestasis, alagille syndrome, biliary atresia, pruritis, FDA, bile acid cotransporter.

Graphical Abstract
[1]
Rothman S. Physiology of itching. Physiol Rev 1941; 21(2): 357-81.
[http://dx.doi.org/10.1152/physrev.1941.21.2.357]
[2]
Rajagopalan M, Saraswat A, Godse K, et al. Diagnosis and management of chronic pruritus: An expert consensus review. Indian J Dermatol 2017; 62(1): 7-17.
[http://dx.doi.org/10.4103/0019-5154.198036] [PMID: 28216719]
[3]
Ständer S, Steinhoff M, Schmelz M, Weisshaar E, Metze D, Luger T. Neurophysiology of pruritus. Arch Dermatol 2003; 139(11): 1463-70.
[http://dx.doi.org/10.1001/archderm.139.11.1463] [PMID: 14623706]
[4]
Patel T, Yosipovitch G. Therapy of pruritus. Expert Opin Pharmacother 2010; 11(10): 1673-82.
[http://dx.doi.org/10.1517/14656566.2010.484420] [PMID: 20426711]
[5]
Weisshaar E, Apfelbacher C, Jäger G, et al. Pruritus as a leading symptom: clinical characteristics and quality of life in German and Ugandan patients. Br J Dermatol 2006; 155(5): 957-64.
[http://dx.doi.org/10.1111/j.1365-2133.2006.07430.x] [PMID: 17034525]
[6]
Garibyan L, Rheingold CG, Lerner EA. Understanding the pathophysiology of itch. Dermatol Ther 2013; 26(2): 84-91.
[http://dx.doi.org/10.1111/dth.12025] [PMID: 23551365]
[7]
Lipman ZM, Ingrasci G, Yosipovitch G. Approach to the patient with chronic pruritus. Med Clin North Am 2021; 105(4): 699-721.
[http://dx.doi.org/10.1016/j.mcna.2021.04.007] [PMID: 34059246]
[8]
Ständer S, Stumpf A, Osada N, Wilp S, Chatzigeorgakidis E, Pfleiderer B. Gender differences in chronic pruritus: women present different morbidity, more scratch lesions and higher burden. Br J Dermatol 2013; 168(6): 1273-80.
[http://dx.doi.org/10.1111/bjd.12267] [PMID: 23387396]
[9]
Schmelz M, Schmidt R, Bickel A, Handwerker HO, Torebjörk HE. Specific C-receptors for itch in human skin. J Neurosci 1997; 17(20): 8003-8.
[http://dx.doi.org/10.1523/JNEUROSCI.17-20-08003.1997] [PMID: 9315918]
[10]
Ikoma A, Steinhoff M, Ständer S, Yosipovitch G, Schmelz M. The neurobiology of itch. Nat Rev Neurosci 2006; 7(7): 535-47.
[http://dx.doi.org/10.1038/nrn1950] [PMID: 16791143]
[11]
Kini SP, DeLong LK, Veledar E, McKenzie-Brown AM, Schaufele M, Chen SC. The impact of pruritus on quality of life: the skin equivalent of pain. Arch Dermatol 2011; 147(10): 1153-6.
[http://dx.doi.org/10.1001/archdermatol.2011.178] [PMID: 21680760]
[12]
Jovanovic M, Oliwifcki S, Beck MH. Occupational contact urticaria from beef associated with hand eczema. Contact Dermat 1992; 27(3): 188-9.
[http://dx.doi.org/10.1111/j.1600-0536.1992.tb05253.x] [PMID: 1451468]
[13]
Jovanović M, Poljački M, Mimica-Dukić N, et al. Sesquiterpene lactone mix patch testing supplemented with dandelion extract in patients with allergic contact dermatitis, atopic dermatitis and non-allergic chronic inflammatory skin diseases. Contact Dermat 2004; 51(3): 101-10.
[http://dx.doi.org/10.1111/j.0105-1873.2004.00413.x] [PMID: 15479198]
[14]
Misery L, Brenaut E, Le Garrec R, et al. Neuropathic pruritus. Nat Rev Neurol 2014; 10(7): 408-16.
[http://dx.doi.org/10.1038/nrneurol.2014.99] [PMID: 24912513]
[15]
Davidson S, Giesler GJ. The multiple pathways for itch and their interactions with pain. Trends Neurosci 2010; 33(12): 550-8.
[http://dx.doi.org/10.1016/j.tins.2010.09.002] [PMID: 21056479]
[16]
Greaves MW. Pathogenesis and treatment of pruritus. Curr Allergy Asthma Rep 2010; 10(4): 236-42.
[http://dx.doi.org/10.1007/s11882-010-0117-z] [PMID: 20428977]
[17]
Misery L, Dutray S, Chastaing M, Schollhammer M, Consoli SG, Consoli SM. Psychogenic itch. Transl Psychiatry 2018; 8(1): 52.
[http://dx.doi.org/10.1038/s41398-018-0097-7] [PMID: 29491364]
[18]
Reamy BV, Bunt CW, Fletcher S. A diagnostic approach to pruritus. Am Fam Physician 2011; 84(2): 195-202.
[PMID: 21766769]
[19]
Robinson HM Jr, Robinson RC, Strahan JF. Hydroxyzine (atarax) hydrochloride in dermatological therapy. J Am Med Assoc 1956; 161(7): 604-6.
[http://dx.doi.org/10.1001/jama.1956.02970070036009] [PMID: 13318971]
[20]
Kar S, Krishnan A, Preetha K, Mohankar A. A review of antihistamines used during pregnancy. J Pharmacol Pharmacother 2012; 3(2): 105-8.
[PMID: 22629082]
[21]
Tashiro M, Horikawa E, Mochizuki H, et al. Effects of fexofenadine and hydroxyzine on brake reaction time during car-driving with cellular phone use. Hum Psychopharmacol 2005; 20(7): 501-9.
[http://dx.doi.org/10.1002/hup.713] [PMID: 16086364]
[22]
Banerji A, Long AA, Camargo CA Jr. Diphenhydramine versus nonsedating antihistamines for acute allergic reactions: A literature review. Allergy Asthma Proc 2007; 28(4): 418-26.
[http://dx.doi.org/10.2500/aap.2007.28.3015]
[23]
Yeung WF, Chung KF, Yung KP, Ng THY. Doxepin for insomnia: A systematic review of randomized placebo-controlled trials. Sleep Med Rev 2015; 19: 75-83.
[http://dx.doi.org/10.1016/j.smrv.2014.06.001] [PMID: 25047681]
[24]
Weber J, Siddiqui MAA, Wagstaff AJ, McCormack PL. Low-Dose Doxepin. CNS Drugs 2010; 24(8): 713-20.
[http://dx.doi.org/10.2165/11200810-000000000-00000] [PMID: 20658801]
[25]
Scharf M, Rogowski R, Hull S, et al. Efficacy and safety of doxepin 1 mg, 3 mg, and 6 mg in elderly patients with primary insomnia: a randomized, double-blind, placebo-controlled crossover study. J Clin Psychiatry 2008; 69(10): 1557-64.
[http://dx.doi.org/10.4088/JCP.v69n1005] [PMID: 19192438]
[26]
Chadwick D. Gabapentin. Lancet 1994; 343(8889): 89-91.
[http://dx.doi.org/10.1016/S0140-6736(94)90820-6] [PMID: 7903783]
[27]
Bockbrader HN, Wesche D, Miller R, Chapel S, Janiczek N, Burger P. A comparison of the pharmacokinetics and pharmacodynamics of pregabalin and gabapentin. Clin Pharmacokinet 2010; 49(10): 661-9.
[http://dx.doi.org/10.2165/11536200-000000000-00000] [PMID: 20818832]
[28]
Wiffen PJ, Derry S, Bell RF, et al. Gabapentin for chronic neuropathic pain in adults. Cochrane Database Syst Rev 2017; 6(6): CD007938.
[http://dx.doi.org/10.1002/14651858.CD007938.pub4]
[29]
Yuan CM, Spandorfer PR, Miller SL, Henretig FM, Shaw LM. Evaluation of tricyclic antidepressant false positivity in a pediatric case of cyproheptadine (periactin) overdose. Ther Drug Monit 2003; 25(3): 299-304.
[http://dx.doi.org/10.1097/00007691-200306000-00009] [PMID: 12766557]
[30]
Merhar SL, Pentiuk SP, Mukkada VA, Meinzen-Derr J, Kaul A, Butler DR. A retrospective review of cyproheptadine for feeding intolerance in children less than three years of age: effects and side effects. Acta Paediatr 2016; 105(8): 967-70.
[http://dx.doi.org/10.1111/apa.13477] [PMID: 27194450]
[31]
Scott DW, Rothstein E, Miller WH Jr. A clinical study on the efficacy of two commercial veterinary pramoxine cream rinses in the management of pruritus in atopic dogs. Canine Pract 2000; 25(2): 15-7.
[32]
Young TA, Patel TS, Camacho F, et al. A pramoxine-based anti-itch lotion is more effective than a control lotion for the treatment of uremic pruritus in adult hemodialysis patients. J Dermatolog Treat 2009; 20(2): 76-81.
[http://dx.doi.org/10.1080/09546630802441218] [PMID: 18821119]
[33]
Ye JH, Ponnudurai R, Schaefer R. Ondansetron: a selective 5-HT(3) receptor antagonist and its applications in CNS-related disorders. CNS Drug Rev 2001; 7(2): 199-213.
[http://dx.doi.org/10.1111/j.1527-3458.2001.tb00195.x] [PMID: 11474424]
[34]
Ashmore SD, Jones CH, Newstead CG, Daly MJ, Chrystyn H. Ondansetron therapy for uremic pruritus in hemodialysis patients. Am J Kidney Dis 2000; 35(5): 827-31.
[http://dx.doi.org/10.1016/S0272-6386(00)70251-4] [PMID: 10793015]
[35]
Mak MF, Li W, Mahadev A. Calamine lotion to reduce skin irritation in children with cast immobilisation. J Orthop Surg (Hong Kong) 2013; 21(2): 221-5.
[http://dx.doi.org/10.1177/230949901302100222] [PMID: 24014789]
[36]
Liang SE, Homayounfar G, Heilman E, Liebman TN. Acquired ichthyosis in the setting of active pulmonary tuberculosis. J Clin Aesthet Dermatol 2019; 12(6): 42-4.
[PMID: 31360287]
[37]
Wildsmith JA. Lidocaine: A more complex story than’simple’chemistry suggests. Proc History Anaesthesia Society 2011; 43: 9-16.
[38]
Inan S, Dun NJ, Cowan A. Inhibitory effect of lidocaine on pain and itch using formalin-induced nociception and 5′-guanidinonaltrindole-induced scratching models in mice: Behavioral and neuroanatomical evidence. Eur J Pharmacol 2009; 616(1-3): 141-6.
[http://dx.doi.org/10.1016/j.ejphar.2009.06.026] [PMID: 19549515]
[39]
Corsico AG, Leonardi S, Licari A, et al. Focus on the cetirizine use in clinical practice: a reappraisal 30 years later. Multidiscip Respir Med 2019; 14(1): 40.
[http://dx.doi.org/10.1186/s40248-019-0203-6] [PMID: 31827796]
[40]
Zhang L, Cheng L, Hong J. The clinical use of cetirizine in the treatment of allergic rhinitis. Pharmacology 2013; 92(1-2): 14-25.
[http://dx.doi.org/10.1159/000351843] [PMID: 23867423]
[41]
Aronson JK, Ed. Meyler’s side effects of drugs: the international encyclopedia of adverse drug reactions and interactions. Elsevier 2015.
[42]
Sweetman SC. Dose adjustment in renal impairment: Response from Martindale: The Complete Drug Reference. BMJ 2005; 331(7511): 292-3.
[43]
Nounou MM, El-Khordagui LK, Khalafallah N. Effect of various formulation variables on the encapsulation and stability of dibucaine base in multilamellar vesicles. Acta Pol Pharm 2005; 62(5): 369-79.
[PMID: 16459486]
[44]
Day C, Bailey CJ. Metformin. xPharm: the comprehensive pharmacology reference Amsterdam Elsevier. 2011.
[45]
Altamura AC, Moro AR, Percudani M. Clinical pharmacokinetics of fluoxetine. Clin Pharmacokinet 1994; 26(3): 201-14.
[http://dx.doi.org/10.2165/00003088-199426030-00004] [PMID: 8194283]
[46]
Benfield P, Heel RC, Lewis SP. Fluoxetine. Drugs 1986; 32(6): 481-508.
[http://dx.doi.org/10.2165/00003495-198632060-00002] [PMID: 2878798]
[47]
Eshtiaghi P, Gooderham MJ. Dupilumab: an evidence-based review of its potential in the treatment of atopic dermatitis. Core Evid 2018; 13: 13-20.
[http://dx.doi.org/10.2147/CE.S133661] [PMID: 29503598]
[48]
D’Ippolito D, Pisano M. Dupilumab (Dupixent): an interleukin-4 receptor antagonist for atopic dermatitis. P&T 2018; 43(9): 532-5.
[PMID: 30186024]
[49]
James DK, Steer PJ, Weiner CP, Gonik B. High Risk Pregnancy E-Book: Management Options-Expert Consult. Amsterdam Elsevier Health Sciences 2010.
[50]
Mishra AK, Kumar A, Singh H, Verma S, Sahu JK, Mishra A. Chemistry and pharmacology of luliconazole (imidazole derivative): a novel bioactive compound to treat fungal infection-a mini review. Curr Bioact Compd 2020; 15(6): 602-9.
[http://dx.doi.org/10.2174/1573407214666180717111419]
[51]
Khanna D, Bharti S. Luliconazole for the treatment of fungal infections: an evidence-based review. Core Evid 2014; 9: 113-24.
[http://dx.doi.org/10.2147/CE.S49629] [PMID: 25285056]
[52]
Scher RK, Nakamura N, Tavakkol A. Luliconazole: a review of a new antifungal agent for the topical treatment of onychomycosis. Mycoses 2014; 57(7): 389-93.
[http://dx.doi.org/10.1111/myc.12168] [PMID: 24621346]
[53]
Tuba Z, Mahó S, Sánta C. Corticosteroids: From natural products to useful analogues Analogue-based Drug Discovery. Hoboken, New Jersey: Wiley VCH 2006; p. 419.
[http://dx.doi.org/10.1002/3527608001.ch22]
[54]
Roeder A, Schaller M, Schäfer-Korting M, Korting HC. Safety and efficacy of fluticasone propionate in the topical treatment of skin diseases. Skin Pharmacol Physiol 2005; 18(1): 3-11.
[http://dx.doi.org/10.1159/000081680] [PMID: 15608497]
[55]
Vanas A, Bronsky E, Dockhorn R, et al. Once daily fluticasone propionate is as effective for perennial allergic rhinitis as twice daily beclomethasone diproprionate. J Allergy Clin Immunol 1993; 91(6): 1146-54.
[http://dx.doi.org/10.1016/0091-6749(93)90317-9] [PMID: 8509578]
[56]
Wahlgren CF, Hägermark Ö, Bergström R, Hedin B. Evaluation of a new method of assessing pruritus and antipruritic drugs. Skin Pharmacol Physiol 1988; 1(1): 3-13.
[http://dx.doi.org/10.1159/000210746] [PMID: 3272748]
[57]
Bonner JJ, Burt H, Johnson TN, Whitaker MJ, Porter J, Ross RJ. Development and verification of an endogenous PBPK model to inform hydrocortisone replacement dosing in children and adults with cortisol deficiency. Eur J Pharm Sci 2021; 165: 105913.
[http://dx.doi.org/10.1016/j.ejps.2021.105913] [PMID: 34146682]
[58]
Gupta AK, Adamiak A, Chow M. Tacrolimus: a review of its use for the management of dermatoses. J Eur Acad Dermatol Venereol 2002; 16(2): 100-14.
[http://dx.doi.org/10.1046/j.1468-3083.2002.00380.x] [PMID: 12046809]
[59]
Dheer D. Jyoti, Gupta PN, Shankar R. Tacrolimus: An updated review on delivering strategies for multifarious diseases. Eur J Pharm Sci 2018; 114: 217-27.
[http://dx.doi.org/10.1016/j.ejps.2017.12.017] [PMID: 29277665]
[60]
Peters DH, Fitton A, Plosker GL, Faulds D. Tacrolimus. Drugs 1993; 46(4): 746-94.
[http://dx.doi.org/10.2165/00003495-199346040-00009] [PMID: 7506654]
[61]
Olsen EA, Cornell RC. Topical clobetasol-17-propionate: Review of its clinical efficacy and safety. J Am Acad Dermatol 1986; 15(2): 246-55.
[http://dx.doi.org/10.1016/S0190-9622(86)70164-3] [PMID: 3528243]
[62]
Del Rosso JQ. Topical corticosteroid therapy for psoriasis—a review of clobetasol propionate 0.025% cream and the clinical relevance of penetration modification. J Clin Aesthet Dermatol 2020; 13(2): 22-9.
[PMID: 32308782]
[63]
Spencer CM, Wagstaff AJ. Prednicarbate. BioDrugs 1998; 9(1): 61-86.
[http://dx.doi.org/10.2165/00063030-199809010-00006] [PMID: 18020557]
[64]
Gupta AK, Chow M. Prednicarbate (dermatop): a review. J Drugs Dermatol 2004; 3(5): 553-6.
[PMID: 15552608]
[65]
Wang J, Su B, Jiang H, et al. Traditional uses, phytochemistry and pharmacological activities of the genus Cinnamomum (Lauraceae): A review. Fitoterapia 2020; 146: 104675.
[http://dx.doi.org/10.1016/j.fitote.2020.104675] [PMID: 32561421]
[66]
Hamidpour R, Hamidpour S, Hamidpour M, Shahlari M. Camphor (Cinnamomum camphora), a traditional remedy with the history of treating several diseases. Int J Case Rep Imag 2013; 4(2): 86-9.
[http://dx.doi.org/10.5348/ijcri-2013-02-267-RA-1]
[67]
Biospace. Albireo Announces FDA Approval of Bylvay™ (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC). Available from: https://www.biospace.com/article/releases/albireo-annou nces-fda-approval-of-bylvay-odevixibat-the-first-drug-treatment-for-patients-with-progressive-familial-intrahepatic-cholestasis-pfic-/ (Accessed on: Dec 2021).
[68]
Donkers JM, Roscam Abbing RLP, van de Graaf SFJ. Developments in bile salt based therapies: A critical overview. Biochem Pharmacol 2019; 161: 1-13.
[http://dx.doi.org/10.1016/j.bcp.2018.12.018] [PMID: 30582898]
[69]
Yang N, Dong YQ, Jia GX, et al. ASBT(SLC10A2): A promising target for treatment of diseases and drug discovery. Biomed Pharmacother 2020; 132: 110835.
[http://dx.doi.org/10.1016/j.biopha.2020.110835] [PMID: 33035828]
[70]
Baghdasaryan A, Fuchs CD, Österreicher CH, et al. Inhibition of intestinal bile acid absorption improves cholestatic liver and bile duct injury in a mouse model of sclerosing cholangitis. J Hepatol 2016; 64(3): 674-81.
[http://dx.doi.org/10.1016/j.jhep.2015.10.024] [PMID: 26529078]
[71]
Fickert P, Pollheimer MJ, Beuers U, et al. Characterization of animal models for primary sclerosing cholangitis (PSC). J Hepatol 2014; 60(6): 1290-303.
[http://dx.doi.org/10.1016/j.jhep.2014.02.006] [PMID: 24560657]
[72]
Bylvay: EPAR-Product information. Available from: https://www.ema.europa.eu/en/documents/assessment-report/bylvay-epar-public-assessment-report_en.pdf (Accessed on Sep, 2021).
[73]
BYLVAY (Odevixibat Capsules) drug. Available from: https://www.rxlist.com/bylvay-drug.htm #description (Accessed on Dec, 2021).
[74]
Kamath BM, Stein P, Houwen RHJ, Verkade HJ. Potential of ileal bile acid transporter inhibition as a therapeutic target in Alagille syndrome and progressive familial intrahepatic cholestasis. Liver Int 2020; 40(8): 1812-22.
[http://dx.doi.org/10.1111/liv.14553] [PMID: 32492754]
[75]
Bifeprunox - Atypical Antipsychotic Drug. 2004. Available from: https://www.clinicaltrialsarena.com/projects/bylvay-odev ixibat-pfic/ (Accessed on: Dec, 2021).
[76]
Reimbursed Access to Bylvay® (odevixibat) Approved in France for Patients with PFIC 1 & 2. Available from: https://www.bloomberg.com/press-releases/2022-11-30/reimbursed-access-to-bylvay-odevixibat-approved-in-francefor-patients-with-pfic-1-2
[77]
Albireo announces FDA approval of Bylvay™ (odevixibat), the first drug treatment for patients with progressive familial intrahepatic cholestasis (PFIC). Available from: https://ir.albireopharma.com/news-releases/news-release-details/albireo-announces-fda-approval-bylvaytmodevixibat-first-drug (Accessed on: July 2022).
[78]
Chiang JY. Bile acid metabolism and signaling. Compr Physiol 2013; 3(3): 1191-212.
[http://dx.doi.org/10.1002/cphy.c120023] [PMID: 23897684]
[79]
Russell DW. The enzymes, regulation, and genetics of bile acid synthesis. Annu Rev Biochem 2003; 72(1): 137-74.
[http://dx.doi.org/10.1146/annurev.biochem.72.121801.161712] [PMID: 12543708]
[80]
Karpen SJ, Kelly D, Mack C, Stein P. Ileal bile acid transporter inhibition as an anticholestatic therapeutic target in biliary atresia and other cholestatic disorders. Hepatol Int 2020; 14(5): 677-89.
[http://dx.doi.org/10.1007/s12072-020-10070-w] [PMID: 32653991]
[81]
Düll MM, Kremer AE. Newer approaches to the management of pruritus in cholestatic liver disease. Curr Hepatol Rep 2020; 19(2): 86-95.
[http://dx.doi.org/10.1007/s11901-020-00517-x]
[82]
Hegyi P, Maléth J, Walters JR, Hofmann AF, Keely SJ. Guts and gall: bile acids in regulation of intestinal epithelial function in health and disease. Physiol Rev 2018; 98(4): 1983-2023.
[http://dx.doi.org/10.1152/physrev.00054.2017] [PMID: 30067158]
[83]
Slavetinsky C, Sturm E. Odevixibat and partial external biliary diversion showed equal improvement of cholestasis in a patient with progressive familial intrahepatic cholestasis. BMJ Case Reports CP 2020; 13(6): e234185.
[http://dx.doi.org/10.1136/bcr-2019-234185]
[84]
Al-Dury S, Wahlström A, Wahlin S, et al. Pilot study with IBAT inhibitor A4250 for the treatment of cholestatic pruritus in primary biliary cholangitis. Sci Rep 2018; 8(1): 6658.
[http://dx.doi.org/10.1038/s41598-018-25214-0] [PMID: 29704003]
[85]
Grammatikopoulos T, Thompson C, Soufi N, et al. Long-term safety and tolerability of odevixibat, an ileal bile acid transporter inhibitor, in children with progressive familial intrahepatic cholestasis: results from the phase 3 PEDFIC 1 and PEDFIC 2 studies. J Pediatr Gastroenterol Nutr 2021; 72 (Suppl. 1): 781-2.
[86]
Odevixibat. Available from: https://www.medkoo.com/produc ts/12904 (Accessed on Dec, 2021).
[87]
MedChemExpresss. Available from: https://www.medchemexpress.com/odevixibat.html (Accessed on Dec, 2021).
[88]
Thompson RJ, Kjems L, Hardikar W, Lainka E, Calvo PL, Horn P. PMU62 Improved quality of life in children with progressive familial intrahepatic cholestasis following 24 weeks of treatment with odevixibat, an ileal bile acid transporter inhibitor: Results from the phase 3 PEDFIC 1 study. Value Health 2021; 24: S155.
[http://dx.doi.org/10.1016/j.jval.2021.04.774]
[89]
Thompson RJ, Arnell H, Artan R, et al. Odevixibat treatment in progressive familial intrahepatic cholestasis: A randomised, placebo-controlled, phase 3 trial. Lancet Gastroenterol Hepatol 2022; 7(9): 830-42.
[http://dx.doi.org/10.1016/S2468-1253(22)00093-0] [PMID: 35780807]
[90]
Ray K. Positive phase III results for odevixibat for progressive familial intrahepatic cholestasis. Nat Rev Gastroenterol Hepatol 2022; 19(9): 556.
[http://dx.doi.org/10.1038/s41575-022-00667-x] [PMID: 35879356]
[91]
Baumann U, Sturm E, Lacaille F, et al. Effects of odevixibat on pruritus and bile acids in children with cholestatic liver disease: Phase 2 study. Clin Res Hepatol Gastroenterol 2021; 45(5): 101751.
[http://dx.doi.org/10.1016/j.clinre.2021.101751] [PMID: 34182185]
[92]
Kohut TJ, Gilbert MA, Loomes KM. Alagille syndrome: A focused review on clinical features, genetics, and treatment. Semin Liver Dis 2021; 41(4): 525-37.
[http://dx.doi.org/10.1055/s-0041-1730951]
[93]
Gwaltney C, Ivanescu C, Karlsson L, Warholic N, Kjems L, Horn P. Validation of the PRUCISION instruments in pediatric patients with progressive familial intrahepatic cholestasis. Adv Ther 2022; 39(11): 5105-25.
[http://dx.doi.org/10.1007/s12325-022-02262-7] [PMID: 36066745]
[94]
Native Liver Survival in Odevixibat sBA Responders: Data From the Pedfic Studies in Patients With Progressive Familial Intrahepatic Cholestasis. Available from: https://www.aasld.org/the-liver-meeting/native-liver-survival-odevixibat-sba-responders-data-pedfic-studies-patients (Accessed on March, 2022).

Rights & Permissions Print Cite
© 2024 Bentham Science Publishers | Privacy Policy