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诺华宣布 IL-17A抑制剂Cosentyx获批第五类适应症
Recently, Swiss company Novartis announced that the U.S. FDA has approved Cosentyx® (secukinumab) for the treatment of active entheseal-related arthritis (ERA) in patients four years and older and juvenile psoriatic arthritis (JPsA) in patients two years and older. Cosentyx is a subcutaneous injection whose active ingredient is secukinumab, an antibody that attaches to interleukin IL-17A and prevents IL-17A from binding to its receptor, thereby inhibiting the inflammatory response in psoriasis caused by IL-17A.
Source: Bing
Cosentyx’s approval status
Previously, Cosentyx has been approved by the FDA to treat psoriasis, psoriatic arthritis, ankylosing spondylitis, and active non-radiographic axial spondyloarthritis (nr-axSpA), which is the fifth approved indication. In July 2020, Cosentyx was approved by the European Union as a first-line systemic treatment for psoriasis in children aged 6 to 18 years, and has recently been approved in the United States and China. In 2021, Cosentyx was approved in Japan for the treatment of PSA and psoriasis in children 6 years of age or older, as well as for the treatment of patients with generalized pustular psoriasis.
Cosentyx is the first fully human biologic that directly inhibits interleukin-17A (IL-17A) and the first biologic approved for the treatment of ERA. At the same time, it is the only biologic approved in the United States for children with ERA (4 years and older) and PSA (2 years and older).
Clinical manifestations of ERA and JPsA
ERA and JPsA are autoimmune diseases and are two subtypes of juvenile idiopathic arthritis (JIA). ERA usually appears in male children in late childhood or adolescence. Classic enthesitis is the area where the Achilles tendon and muscle membrane attach to the patella and greater trochanter of the calcaneus. Early hip joint involvement and severe unilateral arch disease are more common. JPsA is characterized by joint swelling and skin psoriasis that can manifest as nail deformity, inflammation of the fingers and/or toes, or grade 1 related psoriasis skin symptoms that, if left untreated, can lead to severe pain and disability.
What is IL-17A?
IL-17A is an important cytokine that participates in inflammatory responses and has biological effects such as regulating osteoclast function. It is related to PsA, moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
Advantages of Cosentyx
Clinical research on Cosentyx has been conducted for more than 14 years and is supported by reliable trial data. Cosentyx has a precise target, can specifically bind to IL-17A from any source, and does not hinder the normal work of other cytokines, demonstrating rapid, long-lasting efficacy and safety in the treatment of inflammatory diseases. Since its launch in 2015, more than 500,000 patients worldwide have been treated with Cosentyx.
Clinical trial data
The FDA's approval is based on data from the JUNIPERA clinical trial, which showed that during treatment period 2 (weeks 12 to 104), patients with active JPsA (n=34; mean age: 12.2 years) who received Cosentyx had longer time to flare and an 85% reduction in flare risk compared with placebo (P<0.001). In addition, patients with active ERA who received Cosentyx (n=52; average age: 13.7 years) had significantly longer time to relapse compared with placebo, and the risk of relapse was reduced by 53%. The safety profile is consistent with previous studies.
Children with ERA and JPsA suffer from physical weakness, reduced quality of life, and even inability to take care of themselves due to disease symptoms. The approval of Cosentyx provides a new and reliable treatment option for children with ERA and JPsA and brings new hope.
References
https://med.sina.com/article_detail_100_2_110554.html
https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis
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