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The U.S. Food and Drug Administration has approved Novartis' (NVS) Cosentyx or secukinumab for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy.


RTTNews | Jun 1, 2021 09:56PM EDT

21:55 Tuesday, June 1, 2021 (RTTNews.com) - The U.S. Food and Drug Administration has approved Novartis' (NVS) Cosentyx or secukinumab 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 Cosentyx approval was based on two Phase III studies evaluating the use of Cosentyx in children aged 6 to less than 18 years with plaque psoriasis. The safety profile reported in the trials was consistent with the safety profile reported in adult plaque psoriasis trials. No new safety signals were observed, Novartis said in a statement.

According to the company, the approved pediatric dosing for Cosentyx is 75 mg or 150 mg depending on the child's weight at the time of dosing and is administered by subcutaneous injection every four weeks after an initial loading regimen.

Cosentyx is 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, ankylosing spondylitis and non-radiographic axial spondyloarthritis (nr-axSpA)14,15,16.

Read the original article on RTTNews ( https://www.rttnews.com/3199149/fda-approves-novartis-cosentyx-to-treat-plaque-psoriasis-in-pediatric-patients.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved






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