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Novartis' Cosentyx has been granted further approval from the China National Medical Products Administration for use in pediatric patients.
Novartis has announced, in an Aug. 17, 2021 press release, that is has been granted further approval from the China National Medical Products Administration for its moderate-to-severe plaque psoriasis treatment, Cosentyx (secukinumab), to be used in pediatric patients who are candidates for systemic therapy or phototherapy.
With this announcement, Cosentyx is the only interleukin inhibitor approved in China for this patient population. The approval decision was made based on the results of two Phase III international studies in pediatric patients, aged 6 years to <18 years, which demonstrated that the therapy had a similar safety profile in children and adolescents as in adults.
“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,” said Todd Fox, Novartis Global Medical Franchise, head of Immunology, Hepatology, and Dermatology, in the press release. “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.”