Instant Report

Date: 20-Aug-2021

China NMPA Approves Novartis’ Cosentyx To Treat Plaque Psoriasis In Pediatric Patients

Novartis announced that the China National Medical Products Administration (NMPA) has further approved Cosentyx (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (six years and older with a 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 6 to < 18 years old, which showed that Cosentyx was as safe in children and adolescents as when used 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. “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 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.

Novartis is committed to making Cosentyx available to young patients who may benefit from the therapy and 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 very limited approved treatments options for JIA and only a minority of patients go on to achieve and maintain an inactive disease state.

Cosentyx is backed by more than 14 years of clinical experience and long-term five-year clinical data across three indications of psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis (AS), as well as real-world evidence. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across AS, PsA and psoriatic disease, with more than 500,000 patients treated worldwide with Cosentyx since launch.

Psoriasis is a chronic, inflammatory disease that affects more than 125 million people worldwide, potentially impacting up to 350,000 children. One-third of psoriasis cases begin in childhood, and of these, the onset is most common during adolescence.

Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only biologic with proven efficacy in all six key manifestations of PsA.