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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 an analyst with research and consulting firm GlobalData.
Ms Alexandra Annis, GlobalData's Analyst covering Immunology, states that the latest approval will bring exciting new treatment options to US patients dissatisfied with current therapies.
Ms Annis explains: "Up to 40% of AS and PsA patients are intolerant of, or are not well-controlled by, anti-tumor 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."
Proof of the drug's effectiveness has been shown by four placebo-controlled Phase III 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.