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Odevixibat

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Odevixibat
Clinical data
Trade namesBylvay
Other namesA4250
License data
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
  • (2S)-2-{[(2R)-2-[({[3,3-Dibutyl-7-(methylsulfanyl)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl]oxy}acetyl)amino]-2-(4-hydroxyphenyl)acetyl]amino}butanoic acid
CAS Number
PubChem CID
IUPHAR/BPS
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
FormulaC37H48N4O8S2
Molar mass740.93 g·mol−1
3D model (JSmol)
  • CCCCC1(CCCC)CN(C2=CC=CC=C2)C2=CC(SC)=C(OCC(=O)N[C@@H](C(=O)N[C@@H](CC)C(O)=O)C3=CC=C(O)C=C3)C=C2S(=O)(=O)N1
  • InChI=1S/C37H48N4O8S2/c1-5-8-19-37(20-9-6-2)24-41(26-13-11-10-12-14-26)29-21-31(50-4)30(22-32(29)51(47,48)40-37)49-23-33(43)39-34(25-15-17-27(42)18-16-25)35(44)38-28(7-3)36(45)46/h10-18,21-22,28,34,40,42H,5-9,19-20,23-24H2,1-4H3,(H,38,44)(H,39,43)(H,45,46)/t28-,34+/m0/s1
  • Key:XULSCZPZVQIMFM-IPZQJPLYSA-N

Odevixibat, sold under the trade name Bylvay, is a medication for the treatment of progressive familial intrahepatic cholestasis (PFIC).[1][4] It is taken by mouth.[1]

The most common side effects include diarrhea, abdominal pain, hemorrhagic diarrhea, soft feces, and hepatomegaly (enlarged liver).[4]

Odevixibat is a reversible, potent, selective inhibitor of the ileal bile acid transporter (IBAT).[4][5][6]

Odevixibat was approved for medical use in the United States and in the European Union in July 2021.[1][2][3][7][8]

Medical uses

In the United States, odevixibat is indicated for the treatment of pruritus in people three months of age and older with progressive familial intrahepatic cholestasis (PFIC).[1] In the European Union it is indicated in people six months of age and older.[2][3]

Mechanism of action

Odevixibat is a reversible inhibitor of the ileal sodium/bile acid transporter which is the transporter responsible for reabsorption of the majority of bile acids in the distal ileum. [9] The reduced absorption of the bile acids in the distal ileum compounds and leads to a decrease in stimulation of FXR, decreasing the inhibition of bile acid synthesis.[10]

Pharmacokinetics

Odevixibat is majorly protein-bound in-vitro. [10] A dose of Odevixibat that is 7.2 mg reaches a Cmax concentration of 0.47 ng/mL with an AUC (0-24h) of 2.19 h*ng/mL. [11] Adult and pediatric patients given the therapeautic dose of Odevixibat did not display plasma concentrations of the drug. [8] Odevixibat is eliminated majorly unchanged. [11] Odevixibat has an average half-life of 2.36 hours.[10]

Adverse effects

Common side effects of Odevixibat include diarrhea, stomach pain, vomiting, abnormal liquid function tests, and a deficiency in vitamins A,D, E and K. [10]

Contraindications

Odevixibat cannot be given to a child on a liquid diet. [11]

Society and culture

In May 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization in the European Union for odevixibat for the treatment of PFIC in people aged six months or older.[4][12] It was approved for medical use in the European Union in July 2021.[2][3]

References

  1. ^ a b c d e "Bylvay- odevixibat capsule, coated pellets". DailyMed. Retrieved 28 July 2021.
  2. ^ a b c d "Bylvay EPAR". European Medicines Agency (EMA). 20 April 2021. Retrieved 28 July 2021.
  3. ^ a b c d "Bylvay". Union Register of medicinal products. Retrieved 23 July 2021.
  4. ^ a b c d "First treatment for rare liver disease". European Medicines Agency (EMA) (Press release). 21 May 2021. Retrieved 21 May 2021. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ^ "Odevixibat". Albireo Pharma. Retrieved 21 May 2021.
  6. ^ Karpen SJ, Kelly D, Mack C, Stein P (September 2020). "Ileal bile acid transporter inhibition as an anticholestatic therapeutic target in biliary atresia and other cholestatic disorders". Hepatology International. 14 (5): 677–689. doi:10.1007/s12072-020-10070-w. PMID 32653991. S2CID 220481607.
  7. ^ "Odevixibat: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 23 July 2021.
  8. ^ a b "Albireo Announces FDA Approval of Bylvay (odevixibat), the First Drug Treatment for Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)". Albireo Pharma (Press release). 20 July 2021. Retrieved 23 July 2021 – via GlobeNewswire.
  9. ^ "Odevixibat". go.drugbank.com. Retrieved 13 June 2022.
  10. ^ a b c d "Odevixibat Uses, Side Effects & Warnings". Drugs.com. Retrieved 11 June 2022.
  11. ^ a b c "Odevixibat Uses, Side Effects & Warnings". Drugs.com. Retrieved 11 June 2022.
  12. ^ "Bylvay: Pending EC decision". European Medicines Agency (EMA). 19 May 2021. Retrieved 21 May 2021.
  • "Odevixibat". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03566238 for "This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC 1 or 2 (PEDFIC 1)" at ClinicalTrials.gov


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