The FDA’s recent approval of Novartis’ cosentyx for the treatment of adults with active ankylosing spondylitis (AS) and psoriatic arthritis (PsA), will propel the drug to blockbuster status, as it now has three approved indications in the US and Europe, according to GlobalData analyst, Alexandra Annis
Cosentyx was first approved for psoriasis in January 2015, and is currently in global phase three development for axial spondyloarthritis, a complication of AS causing fusion of the joints in the spine.
Alexandra Annis, GlobalData’s analyst covering immunology, said that the latest approval will bring exciting new treatment options to US patients dissatisfied with current therapies.
He said: “Up to 40% of AS and PsA patients are intolerant of, or are not well-controlled by, anti-tumour necrosis factor therapy (anti-TNF), which was the only biologic for AS before cosentyx’s approval.
“Traditionally, swathes of AS and PsA sufferers have been left with unmet needs. cosentyx marks a substantial turning-point for these disease areas by offering a novel and efficacious alternative to existing therapies.”
The drug had four placebo-controlled phase three studies. During these trials, the safety and efficacy of cosentyx was tested in over 1,500 adult patients with active AS or PsA who were intolerant or had an inadequate response to anti-TNFs, or who were naïve to biologic therapy.
Both AS and PsA patients who took cosentyx saw statistically significant improvements versus those who took placebos, according to GlobalData.
Annis said: “Following the European approval of cosentyx back in November 2015, the drug will be the first-in-class interleukin-17A (IL-17A) inhibitor to enter the AS and PsA treatment paradigm in the US, giving it a major competitive edge in this market.
“However, while cosentyx has the first-to-market advantage within its class, Eli Lilly’s ixekizumab, an anti-IL-17 agent, is threatening to compete in the PsA and psoriasis markets, as it is currently under regulatory review for both indications.”