FDA approves Novartis Cosentyx® as first intravenous (IV) formulation interleukin-17A antagonist for rheumatic diseases
7 October 2023
Novartis, a global leader in immuno-dermatology and rheumatology, has received approval from the US Food and Drug Administration (FDA) for an intravenous (IV) formulation of Cosentyx® (secukinumab). This approval extends the usage of Cosentyx to treat adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only treatment with an approved IV formulation that specifically targets and blocks interleukin-17A (IL-17A), offering an alternative to tumor necrosis factor alpha (TNF-α) IV therapies in these indications. Patients now have access to a monthly, weight-based dosing option with no pre-medication or lab monitoring requirements. The IV version of Cosentyx is expected to be available in the fourth quarter of 2023.
Dr. Philip J. Mease, Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA, highlighted the significance of this approval, especially for patients who prefer IV infusions or have concerns about self-injections. This IV formulation of Cosentyx provides an additional treatment option with a distinct mechanism of action compared to existing biologic IV therapies.
Christy Siegel, Vice President and Head of Immunology at Novartis US, emphasized the company's commitment to providing healthcare providers and patients with diverse treatment options, leveraging over a decade of clinical research and eight years of real-world experience with Cosentyx.