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FDA approved Cosentyx (secukinumab) for Moderate to Severe Hidradenitis Suppurativa in Adults and Pediatric PatientsThe FDA approved a new use for the drug Cosentyx to treat a painful skin condition

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Key Takeaway
Consider Cosentyx for moderate to severe hidradenitis suppurativa in patients 12 years and older.

The FDA approved Cosentyx (secukinumab) on October 6, 2023, for the treatment of moderate to severe hidradenitis suppurativa in adults and pediatric patients 12 years and older. This approval adds a new indication for the interleukin-17A antagonist, which was previously approved for plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis.

Hidradenitis suppurativa is a chronic inflammatory skin condition characterized by painful nodules and abscesses, often in intertriginous areas. The approval provides clinicians with an additional biologic option targeting the IL-17 pathway for patients with moderate to severe disease. The label includes specific dosing regimens for both adult and pediatric populations, with options for dose escalation in adults who do not adequately respond to initial therapy.

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 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.

Dosing & Administration

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.

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 use for the drug Cosentyx (secukinumab). It can now be used to treat moderate to severe hidradenitis suppurativa, which is a long-term skin condition that causes painful lumps and abscesses, often in skin folds like the armpits or groin. This condition can significantly impact daily life.

This approval means Cosentyx is available for adults and children 12 years and older who have this condition. The drug works by targeting a specific protein in the body's immune system that contributes to inflammation. Doctors now have another treatment option to consider alongside existing therapies.

Cosentyx was already approved for several other inflammatory conditions like plaque psoriasis and psoriatic arthritis. The new approval provides an additional choice for patients and their healthcare providers when managing this challenging skin condition. Different dosing options are available depending on age and response to treatment.

It's important to remember that every medication affects people differently. While this approval expands treatment possibilities, it doesn't mean Cosentyx will work for everyone with hidradenitis suppurativa. Patients should have open conversations with their doctors about whether this treatment might be appropriate for their individual situation.

What this means for you:
A new treatment option is now available for a painful skin condition, but patients should discuss it with their doctor.

Study Details

Study typeFda approval
PublishedOct 2023
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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