FDA Approves Cosentyx (secukinumab) for Moderate to Severe Hidradenitis Suppurativa in Adults and Pediatric Patients

Cosentyx is a human interleukin-17A antagonist.

Cosentyx is indicated for the treatment of moderate to severe hidradenitis suppurativa (HS) in adults and pediatric patients 12 years of age and older. It is also indicated for: moderate to severe plaque psoriasis (PsO) in adults and pediatric patients 6 years and older who are candidates for systemic therapy or phototherapy; active psoriatic arthritis (PsA) in adults and pediatric patients 2 years of age and older; adults with active ankylosing spondylitis (AS); adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation; and active enthesitis-related arthritis (ERA) in pediatric patients 4 years of age and older.

Prior to Cosentyx initiation, complete all age-appropriate vaccinations and evaluate patients for tuberculosis (TB). For hidradenitis suppurativa: 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. If a patient does not adequately respond, consider increasing the dosage to 300 mg every 2 weeks. Subcutaneous dosage in pediatric patients 12 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 ≥ 30 kg and < 90 kg, the dose is 150 mg. For patients ≥ 90 kg, the dose is 300 mg. For other indications: Various subcutaneous and intravenous dosing regimens are specified based on indication, age, weight, and presence of loading doses. Administration of intravenous formulation: Cosentyx for intravenous use must be diluted prior to administration. Administer as an intravenous infusion after dilution over a period of 30 minutes.

Trial data not available in label.

Not reported in label.

Not reported in label.