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  • Bylvay granted orphan drug designation for Alagille syndrome
  • by Lee, Tak-Sun | translator Alice Kang | Oct 16, 2025 06:21am
Will compete with Livmarli
MFDS announces designation effective October 1¡¦ Central Pharmaceutical Affairs Council recognizes the rationale for granting designation
Livmarli in final reimbursement talks, expected to improve patient access
From this month, Bylvay Cap (odevixibat, Ipsen Korea)—which was recently listed for reimbursement as a treatment for progressive familial intrahepatic cholestasis (PFIC)—has been designated as an orphan drug for treating cholestasis-associated symptoms in patients with Alagille syndrome.

The orphan designation is expected to accelerate the indication expansion, as it provides benefits such as expedited review and exemption from application fees. As a result, Bylvay is now poised to compete with GC Biopharma¡¯s Livmarli oral solution (maralixibat chloride), which is currently in the final stage of pricing negotiations for reimbursement for Alagille syndrome in Korea.

According to industry sources on
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