Bylvay
What Bylvay is used for
Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
- PRIME: a priority medicine that the EMA supported early because it may meet an unmet need.
- Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.
Key facts
- Brand
- Bylvay
- Active substance
- odevixibat
- Disease area
- Cholestasis, Intrahepatic
- Medicine group
- Bile and liver therapy
- ATC code
- A05AX
- Marketing authorisation holder
- Ipsen Pharma
- Authorised in the EU since
- 2021
Official information
In the USA
Same active substance: Bylvay
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Bylvay used for?
Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4.4 and 5.1).
What is the active substance in Bylvay?
Bylvay contains odevixibat.
Who makes Bylvay?
The EU marketing authorisation holder is Ipsen Pharma.
Is Bylvay an orphan medicine?
Yes. Bylvay is designated an orphan medicine in the EU, for a rare disease (Cholestasis, Intrahepatic).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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