The FDA has cleared Cosentyx as the first IV formulation interleukin-17A antagonist for adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis
An image of Novartis Campus. (Credit: Novartis AG)
Novartis has received the US Food and Drug Administration (FDA) approval for an intravenous (IV) formulation of Cosentyx (secukinumab) to treat certain rheumatic diseases.
Cosentyx is a fully human biologic that specifically aims and blocks interleukin-17A (IL-17A), a key cytokine.
The FDA has cleared the Cosentyx as first IV formulation interleukin-17A antagonist for adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
The human biologic is said to be the only non-tumour necrosis factor alpha (TNF-α) IV option available in all these indications.
Patients have a monthly 30-minute, weight-based dosing option with Cosentyx’s IV formulation, which doesn’t require any pre-medication or lab testing.
The new IV administration option will be accessible in Q4 2023, the Swiss pharmaceutical firm said.
Novartis US immunology VP and head Christy Siegel said: “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.”
The IV infusion of Cosentyx gives medical professionals the option and flexibility to customise the treatment for each of their patient’s particular needs.
Prescription medicine can now assist a wider spectrum of PsA, AS, and nr-axSpA patients in managing their illness due to the IV and subcutaneous formulations.
Cosentyx has been assessed in the clinic for over 14 years. It is supported by eight 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.
Cosentyx is already approved in more than 100 countries. Recently, it secured approval for JIA and hidradenitis suppurativa in Europe.