Bylvay (odevixibat)
OrphanPRIMEExceptional circumstancesAccelerated assessment
- Region
- 🇪🇺 EU
- Active substance
- odevixibat
- Company
- Ipsen Pharma
- Status
- Authorised
- Therapeutic area
- Cholestasis, Intrahepatic
- CHMP opinion
- Thu 20 May 2021
- EU approval
- Fri 16 Jul 2021
- Designations
- Orphan, PRIME, Exceptional circumstances, Accelerated assessment
- Application
- EMEA/H/C/004691
- ATC
- A05AX
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Kayfanda Authorised · Ipsen Pharma
Follow Bylvay
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.