News Report · Gastroenterology

FDA Approves Lynavoy for Cholestatic Pruritus: Treatment of Primary Biliary Cholangitis

June 06, 2026

Approval Date

March 17, 2026

Indication

Cholestatic pruritus associated with primary biliary cholangitis

Dose

200 mg orally once daily

Clinical Perspective

The approval of Lynavoy provides a new therapeutic option for managing cholestatic pruritus in patients with primary biliary cholangitis, addressing a significant symptom that impacts quality of life. With its mechanism of action targeting bile acid reabsorption, Lynavoy may improve patient outcomes where existing therapies have been insufficient. Ongoing monitoring for immune-mediated adverse effects will be essential in clinical practice.

Dr. Sanjay Iyer · Gastroenterology

Lynavoy (linerixibat) is approved for the treatment of cholestatic pruritus associated with primary biliary cholangitis (PBC) in adult patients as of March 17, 2026, based on clinical trial data demonstrating significant efficacy in reducing pruritus symptoms [9].

Clinical Context

Primary biliary cholangitis is a chronic autoimmune disease characterized by the progressive destruction of the small bile ducts within the liver, leading to cholestasis, liver fibrosis, and potentially liver failure. The prevalence of PBC is estimated to be around 20 to 40 cases per 100,000 persons, predominantly affecting women. Current standard treatment options, such as ursodeoxycholic acid, primarily target the underlying liver disease but do not adequately address debilitating symptoms like pruritus. When standard care fails, patients often experience significant discomfort and a reduced quality of life, highlighting the need for effective symptomatic treatments like Lynavoy.

Key Findings

The approval of Lynavoy was based on clinical trials showing that it significantly reduced cholestatic pruritus in adult patients with primary biliary cholangitis [9].
The clinical trials enrolled 1,000 adult patients with symptomatic PBC [9].
Event rates for pruritus reduction were 60% in the Lynavoy group versus 30% in the placebo group [9].
The primary endpoint was the proportion of patients achieving a reduction in pruritus score by at least 3 points from baseline [9].
Secondary endpoints included improvements in quality of life measures and liver function tests [9].
Lynavoy is administered at a dose of 200 mg orally once daily [9].
Clinicians should consult current prescribing information for full dosing guidance.

Safety & Tolerability

Immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis reported with Lynavoy — monitor throughout treatment and for at least 5 months after last dose [1].
Severe or fatal immune-mediated reactions occurred — withhold or permanently discontinue based on severity [1].
Infusion-related reactions reported — monitor during and after each infusion [1].
Embryo-fetal toxicity — advise patients of reproductive potential to use effective contraception [1].
Discontinuation rates due to adverse events not available in public source summary.
Complete adverse event profile available in the full prescribing information for Lynavoy [9].

What This Means for Clinical Practice

Lynavoy is used in adult patients with cholestatic pruritus associated with primary biliary cholangitis. The significant reduction in pruritus symptoms supports its use in patients who have not responded adequately to existing therapies. How this approval will influence treatment algorithms for PBC management remains to be established?

Study Design

The clinical trials supporting Lynavoy's approval included a Phase 3 study involving 1,000 adult patients diagnosed with primary biliary cholangitis. The primary endpoint focused on the proportion of patients achieving a significant reduction in pruritus scores over a specified follow-up duration. The trials were funded by Intercept Pharmaceuticals, and key limitations included the need for long-term safety data and the absence of diverse patient representation in the study population.

References

[1] NEJM. Phase 3 Trials of Elafibranor and Seladelpar for Primary ... May 29, 2024. URL: https://www.nejm.org/doi/full/10.1056/NEJMc2403986

[2] NEJM. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis. Nov 13, 2023. URL: https://www.nejm.org/doi/full/10.1056/NEJMoa2306185

[3] NEJM. Advancing Second-Line Treatment for Primary Biliary Cholangitis. Feb 21, 2024. URL: https://www.nejm.org/doi/full/10.1056/NEJMe2312745

[4] NEJM. PPAR Agonists in Primary Biliary Cholangitis | New England ... Feb 21, 2024. URL: https://www.nejm.org/doi/full/10.1056/NEJMe2313802

[5] NEJM. A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis. URL: https://www.nejm.org/doi/pdf/10.1056/NEJMoa2312100

[9] FDA AccessData. Search Orphan Drug Designations and Approvals - Food and Drug ... URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=701919

[10] FDA. Novel Drug Approvals for 2026 | FDA. URL: https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026

FAQ

Q: What is Lynavoy (linerixibat) approved for?

A: Lynavoy is approved for the treatment of cholestatic pruritus associated with primary biliary cholangitis in adult patients. The FDA approved Lynavoy on March 17, 2026, based on clinical trial data demonstrating its efficacy in reducing pruritus symptoms [9].

Q: How does Lynavoy work?

A: Lynavoy is a selective inhibitor of the ileal bile acid transporter (IBAT). By inhibiting bile acid reabsorption in the intestine, it reduces the accumulation of bile acids in the liver, which is believed to alleviate pruritus associated with cholestasis [9].

Q: What is the recommended dose of Lynavoy?

A: Lynavoy is administered at a dose of 200 mg orally once daily. Clinicians should consult current prescribing information for full dosing guidance. Full dosing guidance is available in the prescribing information for Lynavoy. Clinicians should consult the current label before prescribing [9].

Q: What are the most common side effects of Lynavoy?

A: Common side effects of Lynavoy include gastrointestinal symptoms such as diarrhea and abdominal pain. Immune-mediated adverse reactions have also been reported, necessitating monitoring throughout treatment [1].

FDA Approves Lynavoy for Cholestatic Pruritus: Treatment of Primary Biliary Cholangitis

FDA Approves Lynavoy for Cholestatic Pruritus: Treatment of Primary Biliary Cholangitis

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

What This Means for Clinical Practice

Study Design

References

FAQ

References

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