Progressive familial intrahepatic cholestasis

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At a Glance

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Regulatory Watchboard

3 events
Jul 2024Livmarli: FDA approved

treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC)

FDAcompleted
Sep 2023Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

Ipsen

TrialRECRUITING
Jul 2021Bylvay: FDA approved

Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). Limitations of use: BYLVAY may not be effective in PFIC type 2 patients with ABCB11 variants resulting in nonfunctional or complete absence of bile salt export pump protein (BSEP-3)

FDAcompleted

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

1 program

FINANCIAL LANDSCAPE SUMMARY

1

Total programs

1

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Patient Assistance Programs1

Bylvay

Ipsen Biopharmaceuticals, Inc.

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Approved Treatments

1 FDA-approved

Bylvay

(ODEVIXIBAT)Orphan drug

Ipsen Biopharmaceuticals, Inc.

Ileal Bile Acid Transporter Inhibitor [EPC]

12.1 Mechanism of Action Odevixibat is a reversible inhibitor of the ileal bile acid transporter (IBAT). It decreases the reabsorption of bile acids (...

Approved Jul 2021FDA label ↗

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Clinical Trial Landscape

No active clinical trials currently recruiting for Progressive familial intrahepatic cholestasis.
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Recent News & Research

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Specialist Network

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