Novartis’ Cosentyx (secukinumab) Receives the US FDA’s Approval for Active Non-Radiographic Axial Spondyloarthritis

Shots:

• The approval is based on P-III PREVENT study assessing the safety and efficacy of Cosentyx (150mg with/out loading dose) vs PBO in 555 adult patients with active nr-axSpA that were biologic treatment naïve or had an inadequate response / were intolerant to an anti-tumor necrosis factor-α therapy (anti-TNFs)
• The P-III PREVENT study resulted in meeting its 1EPs i.e. 40% improvement in ASAS40 @52wks.; improvement in both load and without load arms @16wks. as assessed by ASQoL; @16wks. greater improvement from baseline in the SF-36 PCS score & MCS score; no new safety signals were detected
• Cosentyx is the first and only fully-human biologic targeting IL-17A and has received EMA’s approval for nr-axSpA in Apr’2020

Click here to read full press release/ article | Ref: Novartis | Image: News 18