Progressive Familial Intrahepatic Cholestasis

• FDA approval · 2021-09-29
  FDA Approved: LIVMARLI — Original Application (Mirum Pharmaceuticals Inc.)

  The FDA granted original approval for LIVMARLI (maralixibat chloride) through Mirum Pharmaceuticals' original NDA.

• FDA approval · 2021-07-20
  FDA Approved: BYLVAY — Original Application (Ipsen Biopharmaceuticals, Inc.)

  FDA approved BYLVAY (odevixibat) from Ipsen Biopharmaceuticals as the original application for the treatment of progressive familial intrahe…

• CLINICAL_TRIALS trial_result · 2021-07-12
  Clinical Trial Update: Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis [Phase 2]

  Phase 2 open-label study evaluating efficacy and long-term safety of LUM001 (maralixibat) in progressive familial intrahepatic cholestasis h…

• CLINICAL_TRIALS withdrawal · 2019-03-18
  Clinical Trial Update: A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC) [Phase 3]

  A Phase 3 placebo-controlled trial of maralixibat (SHP625) in pediatric progressive familial intrahepatic cholestasis was withdrawn.

• CLINICAL_TRIALS research · 2013-02-06
  Clinical Trial Update: Buphenyl Therapy for Byler's Disease

  Clinical trial update indicates that Buphenyl therapy for progressive familial intrahepatic cholestasis (Byler disease) is no longer availab…

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