Novartis has announced that the China National Medical Products Administration (NMPA) has further approved Cosentyx for the treatment of moderate-to-severe plaque psoriasis in paediatric patients (six years and older with body weight ≥ 50 kg) who are candidates for systemic therapy or phototherapy, making it the only interleukin inhibitor approved in China for these patients. Cosentyx is already approved in China for the treatment of moderate-to-severe plaque psoriasis in adults and adult ankylosing spondylitis. The approval is based on two phase-III international studies in pediatric patients aged six to < 18 years old, which showed that Cosentyx was as safe in children and adolescents as when used in adults, as per a statement released by Novartis.
“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.
He also said, “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.”
This approval in China follows the recent approval of Cosentyx in the United States and Europe for the treatment of moderate-to-severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy, the statement further said.
It added that Novartis has recently filed for US and European regulatory approval for Cosentyx as a potential treatment in juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), two subtypes of juvenile idiopathic arthritis (JIA). Currently, there are limited approved treatment options for JIA, and only a minority of patients go on to achieve and maintain an inactive disease state.