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YAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYYAYAYYAYY ۱۲۲۲۶۱۲۲۸۲۳۲۲۱۲۲۱۲۲۲۲۸۲۲۱۲۲۲۲۸۲۲۱۲۲۲۲۸۲۲۸۲۲۲۲۸۲۲۱۲۲۲۲۱۲۲۸۲۲۲۲۱۲۲۱۲۲۲۲۱۲۲۸ & NOVARTIS Novartis International AG Novartis Global Communications CH - 4002 Basel Switzerland https://www.novartis.com https://twitter.com/novartisnews MEDIA & INVESTOR RELEASE Novartis Cosentyx® receives FDA approval for the treatment of children and adolescents with enthesitis related arthritis and psoriatic arthritis • New approvals are based on JUNIPERA trial data showing CosentyxⓇ ( secukinumab ) demonstrated reduced flare risk versus placebo and improvement in disease activity observed over two years across both enthesitis - related arthritis ( ERA ) and psoriatic arthritis ( PSA ) in pediatric patients¹ Safety in these pediatric populations was consistent with the known safety profile of Cosentyx² Cosentyx is the only biologic treatment approved for children and adolescents for both ERA ( 4 years of age and older ) and PSA ( 2 years of age and older ) in the US Basel , December 22 , 2021 - Novartis , a leader in rheumatology and immuno - dermatology , today announced the US Food and Drug Administration ( FDA ) has approved CosentyxⓇ ( secukinumab ) for the treatment of active enthesitis - related arthritis ( ERA ) in patients four years and older , and active juvenile psoriatic arthritis ( JPSA ) in patients two years and older¹ . Cosentyx is now the first biologic indicated for ERA , and the only biologic treatment approved for both ERA and PSA in pediatric patients in the US . These are the second and third approvals for Cosentyx in a pediatric population in the US , and Cosentyx now has a total of five indications across rheumatology and dermatology¹ . " Prior research suggests that despite receiving treatment , some children and adolescents with PSA or ERA can continue to experience symptoms , " said Hermine Brunner , M.D. , Cincinnati Children's Hospital . " The findings from the Phase III JUNIPERA trial show that pediatric patients treated with secukinumab demonstrated marked responses throughout the treatment period . This approval is positive news for some patients who continue to struggle with painful symptoms like inflammation of the joints and swollen fingers and toes . " ERA and JPSA , subtypes of juvenile idiopathic arthritis ( JIA ) , are autoimmune diseases³ - 5 . ERA is characterized by joint swelling and pain where tendons and ligaments attach to bone and may present with low back pain or tenderness at the palpation of the hips5 . JPSA is characterized by joint swelling and skin psoriasis and may present with nail changes , inflammation of fingers and / or toes or psoriatic skin changes in a first - degree relative6 . If left untreated , they can lead to high levels of pain and disability 3-5 . " This marks the second and third US pediatric approval this year for Cosentyx , following pediatric psoriasis approval and further reinforces the proven efficacy and safety of the therapy . With more than 500,000 adult and pediatric patients treated worldwide since launch , healthcare professionals and patients can feel confident in Cosentyx , " said Todd Fox , Global