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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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