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Primary biliary cholangitis (PBC): the approved drugs compared for prescribers
Livdelzi side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for primary biliary cholangitis (PBC).
The primary biliary cholangitis (PBC) prescribing guide
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Livdelziseladelpar | |
|---|---|
| Label dated | January 30, 2026 |
| Starting dose | 10mg orally once daily, with or without food, in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA. A bottle holds 30 capsules, a 30-day supply. |
| Dispensing gate | No REMS; baseline clinical and laboratory liver assessment, a check for decompensated cirrhosis, a medication review against the interaction table, prior authorization, and routing to a specialty pharmacy in Gilead's network |
| Required monitoring | Liver tests at baseline and during treatment per routine management, bone health per standard of care, decompensation in patients with cirrhosis; ALP and bilirubin when rifampin starts |
| Example PA threshold | Cigna example: age 18 or older, PBC by 2 of 3 criteria, ursodiol for at least 1 year with an inadequate response or ursodiol intolerance, no hepatic decompensation, a liver specialist; 6 months, then 1 year on response |
| Support line | Gilead Support Path, 1-855-769-7284 (1-855-7-MYPATH), program navigator for benefits investigation and PA and appeals information, co-pay to $0 for commercial plans up to $10,000 a year, Patient Assistance Program for eligible uninsured, Field Reimbursement Manager on request |
- Label dated
- January 30, 2026
- Starting dose
- 10mg orally once daily, with or without food, in combination with UDCA, or as monotherapy in patients unable to tolerate UDCA. A bottle holds 30 capsules, a 30-day supply.
- Dispensing gate
- No REMS; baseline clinical and laboratory liver assessment, a check for decompensated cirrhosis, a medication review against the interaction table, prior authorization, and routing to a specialty pharmacy in Gilead's network
- Required monitoring
- Liver tests at baseline and during treatment per routine management, bone health per standard of care, decompensation in patients with cirrhosis; ALP and bilirubin when rifampin starts
- Example PA threshold
- Cigna example: age 18 or older, PBC by 2 of 3 criteria, ursodiol for at least 1 year with an inadequate response or ursodiol intolerance, no hepatic decompensation, a liver specialist; 6 months, then 1 year on response
- Support line
- Gilead Support Path, 1-855-769-7284 (1-855-7-MYPATH), program navigator for benefits investigation and PA and appeals information, co-pay to $0 for commercial plans up to $10,000 a year, Patient Assistance Program for eligible uninsured, Field Reimbursement Manager on request
FDA decisions for primary biliary cholangitis (PBC)
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- November 27, 2026Saroglitazar, NDA, Zydus TherapeuticsPending
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- January 2026Livdelzi. The interaction section gained new guidance from 3 lab studies, a modeling study and a population study. Exposure data for PBC patients with severe liver impairment were updated from a dedicated study. The letter lists no change to the dose, the approved use or the warnings. FDA letter
- August 2024Livdelzi. Accelerated approval for PBC with ursodiol, or alone when ursodiol cannot be tolerated, based on the drop in ALP. The approval required the AFFIRM outcomes trial, a pregnancy study and a breast milk study. FDA letter
Open trials
Questions prescribers ask about Primary biliary cholangitis (PBC)
Does Livdelzi require a REMS?
No. Livdelzi has no REMS. Its prescribing guide lists what does gate the first fill and its source.
What monitoring does Livdelzi require?
Liver tests at baseline and during treatment per routine management, bone health per standard of care, decompensation in patients with cirrhosis; ALP and bilirubin when rifampin starts.
What do insurers require before covering Livdelzi?
This is one public insurer policy, an example rather than every plan. Cigna example: age 18 or older, PBC by 2 of 3 criteria, ursodiol for at least 1 year with an inadequate response or ursodiol intolerance, no hepatic decompensation, a liver specialist; 6 months, then 1 year on response.
Which support program starts Livdelzi patients on therapy?
Gilead Support Path, 1-855-769-7284 (1-855-7-MYPATH), program navigator for benefits investigation and PA and appeals information, co-pay to $0 for commercial plans up to $10,000 a year, Patient Assistance Program for eligible uninsured, Field Reimbursement Manager on request.
A reference for licensed professionals, checked on November 9, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Primary biliary cholangitis (PBC) page and the first 90 days pages for Livdelzi.