Novartis Secukinumab Granted New Indication in China for Active Psoriatic Arthritis in Adults

On January 9, the official website of the National Medical Products Administration (NMPA) announced that Novartis' secukinumab has been approved for a new indication to treat adult patients with active psoriatic arthritis. This is the third indication for secukinumab in China, following "moderate to severe plaque psoriasis" and "ankylosing spondylitis."

Secukinumab, as the world's first approved fully human interleukin (IL)-17A inhibitor, can specifically neutralize IL-17A from various sources and inhibit its pro-inflammatory effects. IL-17A is a hallmark cytokine involved in the inflammation and disease progression of psoriasis, psoriatic arthritis, and ankylosing spondylitis, playing a cornerstone role in the pathogenesis.

The FUTURE series of studies and the MAXIMISE study have confirmed that secukinumab can rapidly and comprehensively improve disease activity across the six disease dimensions in patients with psoriatic arthritis, including peripheral arthritis, axial involvement, enthesitis, dactylitis, psoriasis, and nail psoriasis. The EXCEED study demonstrated that the efficacy of secukinumab in peripheral arthritis is comparable to adalimumab, and its efficacy in psoriasis is superior to adalimumab.

ULTIMATE Study Demonstrates Secukinumab Significantly Improves Synovitis and Enthesitis as Assessed by Ultrasound in Psoriatic Arthritis Patients at Week 12, with Significant Differences from Placebo as Early as Week 1. FUTURE 5 Data Shows that Nearly 90% of Psoriatic Arthritis Patients Treated with 300mg Secukinumab for 2 Years Show No Radiographic Progression. Clinical Trial Results Over 5 Years Indicate that Secukinumab is Effective and Well-Tolerated in Psoriatic Arthritis Patients.

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