Odevixibat

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]

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
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

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]

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][9] It was approved for medical use in the European Union in July 2021.[2][3]

References
  1. "Bylvay- odevixibat capsule, coated pellets". DailyMed. Retrieved 28 July 2021.
  2. "Bylvay EPAR". European Medicines Agency (EMA). 20 April 2021. Retrieved 28 July 2021.
  3. "Bylvay". Union Register of medicinal products. Retrieved 23 July 2021.
  4. "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. "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. "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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