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BYLVAY Ipsen Pty Ltd
Product name
BYLVAY
Sponsor
Accepted date
Oct-2025
Active ingredients
odevixibat, odevixibat sesquihydrate
Proposed indication
Bylvay (odevixibat as sesquihydrate) is proposed for the treatment of cholestatic pruritus (itching caused by the buildup of bile salts in blood) in Alagille syndrome (ALGS, a rare genetic disorder that affects multiple organ systems, especially the liver and heart) in patients aged 6 months or older.
Application type
C (new indication)
Publication date
Oct-2025
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.