Novartis Announces FDA Approval of Secukinumab Intravenous Formulation for Adult PsA, AS, and nr-axSpA

On October 6, Novartis' secukinumab (brand name: Cosentyx) intravenous injection was approved by the FDA for the treatment of adult psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). This product is the only IL-17A monoclonal antibody intravenous injection approved for marketing and also the second intravenous option for PsA, AS, and nr-axSpA diseases beyond tumor necrosis factor-alpha (TNF-α) inhibitors.

Secukinumab, developed by Novartis, is an IL-17A monoclonal antibody initially formulated as a subcutaneous injection. Secukinumab's subcutaneous injection was first approved in Japan in December 2014, followed by approvals in Europe and the US in January 2015. This subcutaneous injection has been approved for five indications in the United States: 1) Moderate to severe plaque psoriasis in patients aged 6 years and older who are candidates for systemic therapy or phototherapy; 2) Active PsA in patients aged 2 years and older; 3) Adult active AS; 4) Adult active nr-axSpA with objective signs of inflammation; 5) Active enthesitis-related arthritis (ERA) in patients aged 4 years and older.

Secukinumab Instructions

(Source: FDA official website, Version: 2023/7/24)

Philip J. Mease, MD, Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at Swedish Medical Center, said: "There are millions of patients with PsA, AS, and nr-axSpA in the United States, a significant portion of whom require treatment through intravenous infusion for various reasons, including dissatisfaction with self-injection or simply a preference for receiving treatment in a healthcare setting. The approval of Cosentyx's intravenous formulation is an important milestone for patients as it expands their treatment options. Based on the comfort and familiarity of the existing formulation (referring to subcutaneous secukinumab), they can now choose a biologic with a different mechanism of action from currently available intravenous biologics."

Novartis US Vice President and Head of Immunology Christy Siegel said, "At Novartis, we are committed to ensuring that healthcare providers and patients have treatment options available to meet their unique needs. With the approval of Cosentyx as both an intravenous and subcutaneous injection, we can expand the use of Cosentyx, helping more patients manage their condition with a drug validated by over a decade of clinical research and eight years of real-world studies."

Currently, four IL-17A monoclonal antibodies have been approved for marketing globally: netakimab (Biocad/Shanghai Pharma Biochem), ixekizumab (Eli Lilly), bimekizumab (UCB), and secukinumab (Novartis). Among them, only secukinumab has been approved for both intravenous and subcutaneous injection.

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