Cosentyx was previously approved in China for the treatment of moderate-to-severe plaque psoriasis and ankylosing spondylitis in adults
Novartis tower with surrounding buildings. (Credit: Novartis AG.)
Novartis has received the China National Medical Products Administration (NMPA) approval for Cosentyx (secukinumab) to treat plaque psoriasis in children, aged six years and older.
Cosentyx is indicated as a 150mg injection, administered every four weeks, to treat moderate-to-severe plaque psoriasis paediatric patients, weighing at least 50kg.
The drug was previously approved in China for the treatment of moderate-to-severe plaque psoriasis and ankylosing spondylitis (AS) in adults.
Its expanded approval in China follows recent approval in the US and Europe to treat moderate-to-severe plaque psoriasis in paediatric patients, aged six years and above.
Cosentyx is a fully human biologic that works by directly targeting interleukin-17A (IL-17A), a cornerstone cytokine.
IL-17A plays an important role in the development of plaque psoriasis, psoriatic arthritis (PsA), AS and non-radiographic axial spondyloarthritis (nr-axSpA).
Novartis said that Cosentyx is the only biologic effective for all six manifestations of PsA, and is the only interleukin inhibitor approved in China for the indicated patient population.
Novartis global medical franchise immunology, hepatology and dermatology head Todd Fox said: “Psoriasis goes beyond skin symptoms. If left untreated it can become a source of embarrassment, affecting a young person’s self-esteem.
“The approval in China of Cosentyx means we are able to help even more children and adults around the world live their lives to the fullest, by providing them with a safe and effective therapy they can trust.
“With further US and European filings for childhood arthritic conditions, we have taken another step in our ambition to expand Cosentyx to 10 indications over the next 10 years as part of our commitment to immuno-dermatology and rheumatology.”
The NMPA approval is based on two Phase 3 studies, which showed that Cosentyx was as safe in children and adolescents aged between six and 18 years, as when used in adults.
Novartis said that Cosentyx is supported by more than 14 years of clinical experience and five-year clinical data across indications of psoriasis, PsA and AS.
The Swiss drugmaker has recently filed for approval for Cosentyx in the US and Europe to treat juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA).
JPsA and ERA are the two subtypes of juvenile idiopathic arthritis (JIA), which has very limited approved treatment options available.
In a separate development, Novartis has announced positive results from two Phase 3 trials of Beovu (brolucizumab) in treating diabetic macular edema (DME), compared to aflibercept.
The Phase 3 KITE trial studies of Beovu on up to 16-week dosing intervals, and the other KINGFISHER study evaluated the drug dosed every four weeks.
Both trials showed an overall well-tolerated safety profile for Beovu, said the company.