Novartis AG Sponsored ADR pharmaceutical (NVS.US) TreKizumab approved for new indications in China.

On February 3, Novartis AG Sponsored ADR announced that its innovative biological drug Cosentyx (secukinumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication, for the treatment of adult patients with axial spondyloarthritis (axSpA) who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and have active disease without radiographic evidence of sacroiliitis but with elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence. This approval of the nr-axSpA indication is the sixth indication approved in China following approval for severe plaque psoriasis in adults and children, ankylosing spondylitis, psoriatic arthritis, and hidradenitis suppurativa for Cosentyx. Research has shown that interleukin (IL)-17A is a key cytokine involved in the pathogenesis of axSpA, psoriasis, and psoriatic arthritis. As an IL-17A inhibitor, secukinumab specifically neutralizes IL-17A from various sources, inhibits its pro-inflammatory effects, alleviates symptoms of nr-axSpA, and provides long-term benefits for patients. Novartis AG Sponsored ADR stated that patients with axial spondyloarthritis are mainly young and middle-aged individuals who are in their prime working years, and the progression of the disease can severely impact their quality of life and even lead to disability. The approval of the new indication for secukinumab provides more effective treatment options for nr-axSpA patients, with the potential to slow disease progression and support standardized, comprehensive management. Currently, secukinumab has over 10 years of clinical experience in the global field of axSpA, psoriasis, and psoriatic arthritis, with 5 years of long-term clinical research and real-world evidence support, and it is included in the first-line biological treatment guidelines for axSpA in many international and domestic guidelines. Secukinumab, developed by Novartis AG Sponsored ADR, is one of the IL-17A monoclonal antibodies, and has been a success since its approval by the US FDA in December 2014, with sales reaching $1.128 billion in 2016 and expected to break new records in 2024, with global sales reaching $6.141 billion, maintaining a double-digit growth rate (+23.31%). In China, secukinumab was approved for entry in 2019, with an initial market price of 2998 RMB per dose; after being included in medical insurance in 2020, the price was reduced to 1188 RMB per dose, and further reduced to 870 RMB per dose in 2023, making it a huge success in the domestic market with sales reaching 4.092 billion RMB in 2023, accounting for over 40% of the IL inhibitors market.