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FDA approved Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and olderThe FDA has approved a new drug called Cosentyx for treating a serious skin condition

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Key Takeaway
Consider Cosentyx for moderate to severe plaque psoriasis in patients 6 years and older.

The FDA has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. This approval, granted on January 21, 2015, expands the treatment options for this chronic inflammatory skin condition that affects millions of patients.

Cosentyx is a human interleukin-17A antagonist that targets a key cytokine pathway involved in psoriasis pathogenesis. The approval provides clinicians with an additional biologic therapy option for patients who may not have responded adequately to conventional treatments or other biologics.

The drug is administered via subcutaneous injection with a recommended dosage of 300 mg at Weeks 0, 1, 2, 3, and 4, followed by maintenance dosing every 4 weeks. For some adult patients, a 150 mg dose may be acceptable, while pediatric dosing is weight-based.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Cosentyx is a human interleukin-17A antagonist.

Indication & Patient Population

Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy.

Dosing & Administration

Prior to Cosentyx initiation, complete all age-appropriate vaccinations and evaluate patients for tuberculosis (TB). For plaque psoriasis: Subcutaneous dosage in adults: Recommended dosage is 300 mg by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For some patients, a dose of 150 mg may be acceptable. Subcutaneous dosage in pediatric patients 6 years and older: Recommended weight-based dosage is administered by subcutaneous injection at Weeks 0, 1, 2, 3, and 4 and every 4 weeks thereafter. For patients < 50 kg, the dose is 75 mg. For patients ≥ 50 kg, the dose is 150 mg.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The FDA has approved a new drug called Cosentyx for treating moderate to severe plaque psoriasis. This is a chronic skin condition that causes red, scaly patches and can be uncomfortable for many people. Cosentyx works by targeting a specific part of the body's immune system that is involved in this condition, helping to reduce inflammation and skin symptoms.

This approval is for adults and children as young as 6 years old who have not responded well to other treatments like pills or light therapy. It is given as an injection under the skin, with a schedule that starts with several doses close together and then continues every four weeks. For children, the dose is based on their weight to ensure it is safe and effective.

The approval means that doctors now have another option to help patients manage their psoriasis, especially for those who have tried other treatments without success. It is part of a class of drugs called biologics, which are designed to target specific pathways in the body. This can be encouraging news for patients looking for new ways to control their symptoms.

One important thing to remember is that this approval does not mean Cosentyx is right for everyone. Every patient's situation is different, and it is crucial to discuss all treatment options with a healthcare provider. They can help weigh the benefits and risks based on individual health needs and medical history.

What this means for you:
A new treatment option is available, but talk to your doctor to see if it fits your needs.

Study Details

Study typeFda approval
PublishedJan 2015
View Original Abstract ↓
1 INDICATIONS AND USAGE COSENTYX is a human interleukin-17A antagonist indicated for the treatment of: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. ( 1.1 ) active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. ( 1.2 ) adults with active ankylosing spondylitis (AS) . ( 1.3 ) adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. ( 1.4 ) active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. ( 1.5 ) moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. ( 1.6 ) 1.1 Plaque Psoriasis COSENTYX ® is indicated for the treatment of moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older. 1.3 Ankylosing Spondylitis COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS). 1.4 Non-Radiographic Axial Spondyloarthritis COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation. 1.5 Enthesitis-Related Arthritis COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older. 1.6 Hidradenitis Suppurativa COSENTYX is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older.
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