secukinumab

FDA Drug Profile — COSENTYX

Drug Details

Generic Name
secukinumab
Brand Names
COSENTYX
Application Number
BLA125504
Sponsor
Novartis Pharmaceuticals Corporation
NDC Codes
5
Dosage Forms
INJECTION, LIQUID, INJECTION, SOLUTION, CONCENTRATE
Routes
SUBCUTANEOUS, INTRAVENOUS
Active Ingredients
SECUKINUMAB

Indications and Usage

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.