FDA Approves Cosentyx (secukinumab) for moderate to severe plaque psoriasis in adults and pediatric patients 6 years and older
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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.
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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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