Switzerland-based pharmaceutical firm Novartis announced that the European Commission (EC) has approved the up-titration of Cosentyx (secukinumab) to 300mg.
Cosentyx is used for patients with active ankylosing spondylitis (AS), and the approval is based on results of MEASURE 3, a three-year study aimed at evaluating the tolerability and efficacy of Cosentyx in patients with AS.
Novartis said that the 300mg dose group has demonstrated greater response rates among the patients with previous anti-TNF exposure when compared with the 150mg dose, and the previous studies showed a consistent safety profile.
Novartis global immunology, hepatology and dermatology medical affairs head Sam Khalil said: “This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment.
“It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS.”
Cosentyx has treated more than 250,000 patients since its launch
Axial spondyloarthritis (axSpA) is a type of long-term inflammatory disease characterised by chronic inflammatory back pain and includes ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
Both the diseases have comparable symptoms, including nocturnal pain, fatigue, morning stiffness and functional disability, while AS is characterised by joint damage, which is visible on x-ray, and joint damage caused by nr-axSpA are not visible on x-ray.
According to Novartis, Cosentyx is the first and only fully-human biologic, capable of directly inhibiting interleukin-17A (IL-17A).
IL-17A is a cytokine that plays a crucial role in inflammation and development of psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS).
The approval of Cosentyx is supported by sufficient clinical evidence, including 5-year data across PsO, PsA and AS, along with data from real-world evidence.
The company said that the data would strengthen the position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA, and psoriatic disease.
Furthermore, Cosentyx has treated more than 250,000 patients across the world since its launch.