A fully human biologic, Cosentyx has been developed to directly inhibit interleukin-17A (IL-17A), a cytokine.
The regulatory approval is granted for the use of the therapy, either alone or in combination with methotrexate, to treat juvenile idiopathic arthritis (JIA) categories of enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (JPsA) in patients aged six years and above whose disease has responded insufficiently to, or who cannot tolerate the standard therapy.
ERA and JPsA are two JIA forms and are progressive, debilitating autoimmune diseases.
Novartis Medical Affairs Immunology global head Todd Fox said: “Cosentyx could now provide a treatment option for eligible patients who continue to struggle with the painful symptoms which negatively impact their quality of life, such as inflammation of the joints, swollen fingers and toes.
“This approval represents an important step in our ambition to expand Cosentyx to 10 indications for children and adults living with rheumatic and dermatologic diseases.”
The EC approval is based on data obtained from the three-part, placebo-controlled, double-blind, two-year, randomised withdrawal Phase III JUNIPERA trial.
The trail was conducted in 86 children and adolescents aged two to 18 years with ERA and JPsA.
It was found that Cosentyx reduced the flare risk and disease activity compared to placebo over the treatment period of two years in paediatric patients with ERA and PsA.
In these paediatric populations, safety was in line with the known safety profile across approved adult and paediatric indications of Cosentyx.