Novartis Cosentyx receives US FDA approval for treatment of psoriatic arthritis, ankylosing spondylitis & nr-axSpA

Novartis, a global leader in immuno-dermatology and rheumatology, announced that the US FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). Cosentyx is the only treatment approved in an IV formulation that specifically targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-a) IV option available in all these indications. The IV formulation of Cosentyx offers patients a monthly 30 minutes, weight-based dosing option, requiring no pre-medication and no lab monitoring.

The new intravenous administration option will be available in Q4 of 2023.

"A significant portion of the millions of PsA, AS and nr-axSpA patients in the US require treatment through IV infusions for a variety of reasons, including not being comfortable with self-injections or simply preferring to have treatments administered in their healthcare provider's office," said Philip J. Mease, M.D., Clinical Professor at the University of Washington School of Medicine and Director of Rheumatology Research at the Swedish Medical Center in Seattle, WA. "The approval of Cosentyx as an IV formulation is an important milestone for patients because it expands the treatment options available to them with a different mechanism of action than existing biologic IV therapies, along with the comfort and familiarity of an established treatment."

Cosentyx is a fully human biologic that specifically targets and blocks interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 8 years of real-world data in adults and five years of long-term safety and efficacy in adults with moderate to severe plaque psoriasis, PsA and AS. These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA, moderate to severe plaque psoriasis (adult and pediatric) and two subtypes of juvenile idiopathic arthritis (JIA), enthesitis-related arthritis and juvenile psoriatic arthritis. More than one million patients have been treated with Cosentyx worldwide since its launch in 2015.

Cosentyx is approved in more than 100 countries, most recently gaining approval for juvenile idiopathic arthritis and hidradenitis suppurativa in Europe.

"At Novartis, we are committed to ensuring healthcare providers and patients have treatment options available to meet their unique needs. With this approval of Cosentyx as an IV formulation, along with the subcutaneous formulation, we can broaden the use of Cosentyx to help more patients manage their condition with a medicine backed by more than a decade of clinical research and eight years of real-world experience," said Christy Siegel, Vice President and Head of Immunology, Novartis US.

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