FDA approved Cibinqo (abrocitinib) for Refractory Moderate-to-Severe Atopic DermatitisFDA approved new pill Cibinqo for hard-to-treat eczema in adults and teens.

FDA From the archive Source published January 14, 2022 Summary added July 7, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Cibinqo for patients with refractory moderate-to-severe atopic dermatitis who have failed other systemic therapies.

The FDA has approved Cibinqo (abrocitinib), a Janus kinase (JAK) inhibitor, for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. The approval provides a new oral option for patients with difficult-to-treat disease. Cibinqo is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. The recommended dosage is 100 mg once daily, which can be increased to 200 mg once daily if an adequate response is not achieved. Dose adjustments are required for patients with moderate renal impairment and CYP2C19 poor metabolizers. Clinicians should perform tuberculosis evaluation, viral hepatitis screening, and complete blood count prior to initiation.

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

Mechanism of Action

Abrocitinib is a Janus kinase (JAK) inhibitor. The exact mechanism of action in atopic dermatitis is not fully elucidated, but it is thought to inhibit JAK1-mediated signaling pathways involved in inflammation.

Indication & Patient Population

Cibinqo is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants.

Dosing & Administration

The recommended dosage is 100 mg orally once daily. If an adequate response is not achieved, consider increasing to 200 mg once daily. Discontinue if inadequate response after 200 mg once daily. Use the lowest efficacious dose to maintain response. For moderate renal impairment (eGFR 30-59 mL/min), the recommended dose is 50 mg once daily, with possible increase to 100 mg once daily if needed. For CYP2C19 poor metabolizers, the recommended dose is 50 mg once daily, with possible increase to 100 mg once daily if needed. Cibinqo can be taken with or without topical corticosteroids.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Prior to initiation, evaluate for tuberculosis (TB) infection; do not initiate in active TB. For latent TB or high risk, start preventive therapy. Screen for viral hepatitis; do not initiate in active hepatitis B or C. Obtain complete blood count; do not initiate if platelet count <150,000/mm3, absolute lymphocyte count <500/mm3, absolute neutrophil count <1,000/mm3, or hemoglobin <8 g/dL. Complete immunizations, including herpes zoster vaccination, prior to initiation. Discontinue for serious or opportunistic infections. For hematologic abnormalities, follow discontinuation recommendations in the full prescribing information.

Place in Therapy

Cibinqo is an oral JAK inhibitor for patients with refractory moderate-to-severe atopic dermatitis who have failed or are not candidates for other systemic therapies, including biologics. It should not be used in combination with other JAK inhibitors, biologic immunomodulators, or immunosuppressants.

The FDA has approved a new medication called Cibinqo (abrocitinib) for people 12 years and older with moderate-to-severe atopic dermatitis, also known as eczema. This condition causes red, itchy, and inflamed skin. Cibinqo is for patients whose eczema is not well controlled with other systemic treatments, including biologics, or when those treatments are not advisable.

Cibinqo is a once-daily pill that works by blocking certain enzymes (JAKs) involved in inflammation. The starting dose is 100 mg, which can be increased to 200 mg if needed. It should not be taken with other JAK inhibitors, biologic drugs, or strong immunosuppressants. Dose adjustments are needed for people with moderate kidney problems or certain genetic traits.

This approval provides a new oral option for patients who have struggled with hard-to-treat eczema. Before starting Cibinqo, your doctor will check for tuberculosis, hepatitis, and do a blood count. Common side effects include nausea, headache, and acne. Serious risks include infections, blood clots, and changes in blood counts.

If you or your child has eczema that is not improving with current treatments, talk to your doctor about whether Cibinqo might be an option. This medication is not for everyone, and your doctor can help weigh the benefits and risks based on your specific health situation.

What this means for you:

Cibinqo is a new daily pill for hard-to-treat eczema; talk to your doctor to see if it fits your care.

Study Details

Study typeFda approval

PublishedJan 2022

View Original Abstract ↓

1 INDICATIONS AND USAGE CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. Limitations of Use CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or other immunosuppressants. CIBINQO is a Janus kinase (JAK) inhibitor indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. ( 1 ) Limitation of Use : CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

FDA approved Cibinqo (abrocitinib) for Refractory Moderate-to-Severe Atopic DermatitisFDA approved new pill Cibinqo for hard-to-treat eczema in adults and teens.

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FDA approved Cibinqo (abrocitinib) for Refractory Moderate-to-Severe Atopic DermatitisFDA approved new pill Cibinqo for hard-to-treat eczema in adults and teens.

Study Details

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

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Clinical research that matters. Delivered to your inbox.

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