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Drug

Odevixibat sesquihydrate

Approved · EMA

Also known as Bylvay.

RxNorm2563978
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Kayfanda (EMA)

Regulatory2024-09-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Odevixibat sesquihydrate
Aliases & brands
Bylvay
RxNorm CUI
2563978
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-09-19
Latest approval
2024-09-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-09-19Approval
Approval: Kayfanda (EMA)

Indication: Kayfanda is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) in patients aged 6 months or older (see sections 4.4 and 5.1).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Regulatory event sources are credited in the Regulatory Timeline above.