The U.S. Food and Drug Administration (FDA) has approved the inclusion of new evidence that Novartis Pharmaceuticals Corp.’s Cosentyx (secukinumab) significantly slows the progression of joint structural damage at Week 24 versus placebo in those with active psoriatic arthritis (PsA).1
The data will be added to the drug’s prescribing information and is effective in the U.S. immediately. Cosentyx is the first and only interleukin-17A (IL-17A) antagonist approved to treat active PsA, active ankylosing spondylitis, and moderate to severe plaque psoriasis in adults.1
PsA can lead to reduced mobility and irreversible joint damage if left untreated.2,3 The update to the prescribing information is based on data from FUTURE 5, the largest Phase III study for a biologic done in PsA to date (996 patients).
“While daily psoriatic arthritis symptoms can seriously affect a patient, the progressive nature of this disease should not be ignored. The joint damage that often results from having the disease over time can potentially be permanent,” said Marcia Kayath, head of U.S. Clinical Development and Medical Affairs, Novartis. “Now physicians and their patients with psoriatic arthritis can be confident that Cosentyx not only offers significant symptom relief, but also helps slow the progression of the disease.”
PsA affects an estimated 2 million people in the US and is characterized by joint pain and stiffness.3 PsA can lead to irreversible joint damage and disability caused by years of inflammation.3,2
More than 74,000 patients in the US have been prescribed Cosentyx in the post-marketing setting across all indications since launch.4
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References:
1 Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.
2 Villani AP, Rouzaud M, Sevrain M, et al. Prevalence of undiagnosed psoriatic arthritis among psoriasis patients: Systematic review and meta-analysis. J Am Acad Dermatol. 2015;73(2):242-8
3 National Psoriasis Foundation. Media Kit. Available at: https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Last accessed May 2018.
4 Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; February. 2018.
(Source: Novartis Pharmaceuticals Corp.)
