Alagille Syndrome

• EMA approval · 2026-04-17
  EMA Authorised: Livmarli (Maralixibat chloride) — Mirum Pharmaceuticals International B.V.

  The European Medicines Agency has authorised Livmarli (maralixibat) for Alagille syndrome, with orphan medicine designation.

• EMA approval · 2025-07-11
  EMA Authorised: Kayfanda (odevixibat sesquihydrate) — Ipsen Pharma

  The EMA authorised Kayfanda (odevixibat sesquihydrate) for pruritus and Alagille syndrome, manufactured by Ipsen Pharma.

• FDA approval · 2025-04-10
  FDA Approved: LIVMARLI — Original Application (Mirum Pharmaceuticals Inc.)

  The FDA approved LIVMARLI (maralixibat chloride) from Mirum Pharmaceuticals as an original application for the treatment of pruritus in pedi…

• FDA approval · 2024-03-13
  FDA Approved: LIVMARLI — Supplemental Application (Mirum Pharmaceuticals Inc.)

  The FDA approved a supplemental application for LIVMARLI (maralixibat chloride) from Mirum Pharmaceuticals.