Express significantly reduces the risk of disease onset, IL-17A inhibitors are approved for Category 5 indications

▎Editor of WuXi AppTec's content team recently, Novartis announced that the US FDA has approved Cosentyx (secukinumab) for the treatment of active attachment-related arthritis (ERA) 4 years old and older, and activities for patients 2 years and older Juvenile Psoriatic Arthritis (JPsA)
.

The press release states that Cosentyx is the first fully human biological product that can directly inhibit interleukin-17A (IL-17A), the first biological product approved for the treatment of ERA, and the only approved treatment for pediatrics.
Biological products for patients with ERA (≥4 years old) and PsA (≥2 years old)
.

 ERA and JPsA are two subtypes of juvenile idiopathic arthritis (JIA), which are autoimmune diseases
.

ERA is characterized by swelling and pain in the joints attached to the tendons and ligaments of the patient, which can be manifested as low back pain or tenderness during palpation of the hip joint
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JPsA is characterized by joint swelling and psoriasis in patients, which can be manifested as nail deformity, finger and/or toe inflammation, or first-level related psoriasis skin symptoms
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If left untreated, it can lead to high levels of pain and disability
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IL-17A is an important cytokine that causes many inflammatory diseases
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Cosentyx can specifically bind to IL-17A from any source without hindering the normal work of other cytokines
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Because of the precise target and the higher safety brought by fully human antibodies, the drug exhibits rapid and long-lasting efficacy and safety in the treatment of inflammatory diseases
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The drug has been validated by clinical studies for more than 14 years.
Since it was first approved for marketing in 2015, more than 500,000 patients treated worldwide have proven its long-term safety and efficacy
.

Previously, Cosentyx has received FDA approval for the treatment of psoriasis, psoriatic arthritis, ankylosing spondylitis, and active non-radiological axial spondyloarthritis (nr-axSpA)
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 This approval is based on positive data obtained from a 2-year Phase 3 clinical trial
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The results of the trial reached its primary endpoint.
In treatment period 2 (week 12 to week 104), patients with active JPsA treated with Cosentyx (n=34; mean age: 12.
2 years) had a relapse time (time) compared with placebo.
to flare) is longer and the risk of seizures is reduced by 85% (P<0.
001)
.

In addition, patients with active ERA (n=52; mean age: 13.
7 years) who received Cosentyx had a significantly longer relapse time than placebo, and the risk of seizures was reduced by 53%
.

The safety features are consistent with previous studies
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The three leading clinical trial of Dr.
Hermine Brunner commented: "Previous studies have shown that, despite receiving treatment, some of the suffering PsA or ERA of children and young people will continue to emerge joint inflammation and swelling of the fingers and toes pain
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And The results of the Phase 3 JUNIPERA trial showed that pediatric patients treated with Cosentyx showed a significant treatment response throughout the treatment period
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Therefore, this approval is good news for them
.

"Reference: [1] Novartis Cosentyx® Receives FDA Approval For The Treatment Of Children And Adolescents With Enthesitis-Related Arthritis And Psoriatic Arthritis.
Retrieved December 23, 2021, from https:// releases / novartis-cosentyx-receives- fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis Disclaimer: WuXi content teams to focus progress of biomedical research on global health introduction
.

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in the
article .
This article is not a treatment plan recommendation
.

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.