The approval is said to confirm the Cosentyx efficacy in the treatment of axial spondyloarthritis (axSpA) disease spectrus.
Cosentyx is claimed to be the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), a cytokine responsible for the inflammation and development of psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS) and nr-axSpA.
The current approval was based on efficacy and safety data of the PREVENT phase III study, which recruited 555 adult patients with active nr-axSpA that were biologic treatment naïve or had an inadequate response to an anti-tumour necrosis factor-α therapy (anti-TNFs).
The PREVENT is a two-year randomised, double-blind and placebo-controlled phase III study designed to assess the efficacy and safety of Cosentyx in patients with active nr-axSpA.
Its primary endpoints include the proportion of biologic-naïve patients achieving an ASAS40 response with Cosentyx 150mg at weeks 16 and 52 while secondary points comprise of change in BASDAI over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS-CRP).
According to the company, Cosentyx achieved the primary endpoints and demonstrated statistically significant improvements against placebo in the signs and symptoms of nr-axSpA.
The PREVENT clinical trial investigator Dr Atul Deodhar said: “The results from the PREVENT trial show that there was a significant reduction in disease activity for patients treated with Cosentyx versus placebo.
“This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.”
In April this year, Novartis secured European Medicines Agency approval for Cosentyx for the treatment of nr-axSpA.
In May, Novartis secured FDA approval for its Tabrecta (capmatinib) to treat adult patients metastatic non-small cell lung cancer (NSCLC) with MET exon 14 skipping (METex14).
The approval has been granted for Tabrecta, a MET inhibitor, to treat adult patients with NSCLC whose tumours have a mutation, which leads to METex14 as detected by an FDA-approved test.