EMA — authorised 16 July 2021
- Marketing authorisation holder: ALBIREO
- Status: approved
🇪🇺 Bylvay in European Union
EMA authorised Bylvay on 16 July 2021
Marketing authorisations
EMA — authorised 16 July 2021
- Application: EMEA/H/C/004691
- Marketing authorisation holder: Ipsen Pharma
- Local brand name: Bylvay
- Indication: 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).
- Pathway: accelerated assessment, exceptional circumstances, orphan, PRIME
- Status: approved
EMA — authorised 19 September 2024
- Application: EMEA/H/C/006462
- Marketing authorisation holder: Ipsen Pharma
- Local brand name: Kayfanda
- 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).
- Pathway: exceptional circumstances
- Status: approved
The European Medicines Agency (EMA) approved Kayfanda (Bylvay) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) aged 6 months or older. This approval was granted under the exceptional circumstances expedited pathway. Kayfanda is marketed by Ipsen Pharma.
Bylvay in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in European Union
Frequently asked questions
Is Bylvay approved in European Union?
Yes. EMA authorised it on 16 July 2021; EMA authorised it on 16 July 2021; EMA authorised it on 19 September 2024.
Who is the marketing authorisation holder for Bylvay in European Union?
ALBIREO holds the EU marketing authorisation.