FDA approved Tremfya (guselkumab) for Ulcerative Colitis and Crohn's DiseaseFDA approved Tremfya for ulcerative colitis and Crohn's disease.

FDA From the archive Source published July 13, 2017 Summary added June 2, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Tremfya as a treatment option for adults with moderately to severely active ulcerative colitis or Crohn's disease.

The FDA has approved Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease, according to the prescribing label. This marks the first approval of an IL-23 antagonist for both inflammatory bowel disease indications. Tremfya was previously approved for plaque psoriasis and psoriatic arthritis in adults and pediatric patients aged 6 years and older weighing at least 40 kg. The new indication provides an additional biologic option for patients with moderate-to-severe ulcerative colitis or Crohn's disease who have failed conventional therapy. The label includes both intravenous and subcutaneous induction dosing regimens, with subcutaneous maintenance dosing options. Clinicians should note the requirement for baseline liver enzyme and bilirubin testing before initiating therapy for these indications.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Guselkumab is a human IgG1λ monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 (IL-23) and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.

Indication & Patient Population

TREMFYA is indicated for the treatment of: adults with moderately to severely active ulcerative colitis; adults with moderately to severely active Crohn's disease. Also indicated for adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy; and adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis.

Dosing & Administration

For ulcerative colitis and Crohn's disease: Induction: 200 mg IV infusion over at least 1 hour at Weeks 0, 4, and 8 OR 400 mg SC (given as two consecutive 200 mg injections) at Weeks 0, 4, and 8. Maintenance: 100 mg SC at Week 16 and every 8 weeks thereafter OR 200 mg SC at Week 12 and every 4 weeks thereafter. Use lowest effective dosage. Obtain liver enzymes and bilirubin prior to initiation. Complete age-appropriate vaccinations prior to treatment.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindications: None reported in label. Warnings: Infections (including tuberculosis), hypersensitivity reactions, liver enzyme elevations (for UC and CD, obtain LFTs and bilirubin prior to initiation; for PsO and PsA, evaluate if clinically indicated), and risk of immunization with live vaccines. Evaluate for TB prior to initiation.

Place in Therapy

TREMFYA is an IL-23 antagonist approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and moderately to severely active Crohn's disease. It offers a targeted biologic option for patients who are candidates for systemic therapy or phototherapy (PsO) or who have failed conventional therapy (PsA, UC, CD).

The FDA has approved Tremfya (guselkumab) for adults with moderately to severely active ulcerative colitis and Crohn's disease. This is the first time a drug in the IL-23 antagonist class has been approved for both inflammatory bowel diseases. Tremfya was already approved for plaque psoriasis and psoriatic arthritis. The new approval adds another biologic option for patients who have not responded well to other treatments.

Tremfya is given as an intravenous infusion or a subcutaneous injection. The dosing schedule depends on whether it is used for induction (starting treatment) or maintenance (long term). Before starting Tremfya, doctors should check liver enzyme and bilirubin levels. This is a standard safety step for many biologic drugs.

This approval means more choices for patients living with ulcerative colitis or Crohn's disease. However, it is important to remember that every patient is different. What works for one person may not work for another. The decision to use Tremfya should be made with your doctor, who can help weigh the benefits and risks based on your specific health situation.

If you have inflammatory bowel disease and are considering new treatments, talk to your doctor. They can explain how Tremfya works, what side effects to watch for, and whether it might be a good fit for you. This approval is a step forward, but your doctor remains your best resource for personalized care.

What this means for you:

Tremfya is a new option for ulcerative colitis and Crohn's disease, but talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedJul 2017

View Original Abstract ↓

1 INDICATIONS AND USAGE TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis. ( 1.3 ) adults with moderately to severely active Crohn's disease. ( 1.4 ) 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. 1.3 Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 1.4 Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease.

FDA approved Tremfya (guselkumab) for Ulcerative Colitis and Crohn's DiseaseFDA approved Tremfya for ulcerative colitis and Crohn's disease.

Study Details

Guselkumab Phase III trials validate 3VAS and 4VAS measures for psoriatic arthritis disease activity assessment

Study checks how well pain scores track joint damage in psoriatic arthritis patients

Clinical research that matters. Delivered to your inbox.

FDA approved Tremfya (guselkumab) for Ulcerative Colitis and Crohn's DiseaseFDA approved Tremfya for ulcerative colitis and Crohn's disease.

Study Details

Guselkumab Phase III trials validate 3VAS and 4VAS measures for psoriatic arthritis disease activity assessment

Study checks how well pain scores track joint damage in psoriatic arthritis patients

Clinical research that matters. Delivered to your inbox.

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