Novartis receives FDA approval for inclusion of new evidence that Cosentyx® inhibits progression of joint structural damage in psoriatic arthritis

 

Novartis announced today that the U.S. Food and Drug Administration (FDA) approved the inclusion of new evidence that 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 US 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 US 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

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Cosentyx is a fully human monoclonal antibody (mAB) that selectively binds to the interleukin-17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.1

Cosentyx is approved in more than 75 countries, which includes the European Union countries and the US, across all indications - psoriatic arthritis (PsA), psoriasis and ankylosing spondylitis (AS). Cosentyx is approved for the treatment of PsA in 77 countries, including the US, Canada, the European Union countries and Australia.

About the FUTURE 5 data (NCT02404350)5
In the study, participants (n=996) with active psoriatic arthritis (PsA) were randomized to receive Cosentyx 300 mg with loading dose (LD), 150 mg with LD, 150 mg without LD, or placebo. All groups received Cosentyx or placebo at baseline (BL), Weeks 1, 2, 3, and 4, and then every 4 weeks. At Week 16, placebo non-responders (patients with <20% improvement from BL in tender or swollen joint counts) were switched to Cosentyx 300 mg or 150 mg; remaining placebo patients were switched at Week 24. The primary endpoint was ACR20 at Week 16 and the key secondary endpoint was radiographic structural progression, as measured by mTSS, assessed by two blinded readers, based on hand/wrist/foot X-rays obtained at BL, Week 16 (non-responders), and Week 24.

About psoriatic arthritis (PsA)
Closely associated with psoriasis, psoriatic arthritis (PsA) is part of a spectrum of long-term diseases impacting joints, known as spondyloarthritis.3,6 Up to 2 million people are currently diagnosed with PsA in the US and approximately one in four of people with psoriasis may have undiagnosed PsA.3 Symptoms of PsA include joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, and persistent painful tendonitis.3

About Novartis
Located in East Hanover, NJ Novartis Pharmaceuticals Corporation is an affiliate of Novartis which provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 124,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

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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.
  5. Mease P, van der Heijde D, Landewe R, et al. Secukinumab improves active psoriatic arthritis symptoms and inhibits radiographic progression: primary results from the randomised, double-blind, phase III FUTURE 5 study. Ann Rheum Dis.2018; 77:890-897
  6. Spondyloarthritis. American College of Rheumatology (ACR) Web site. https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Spondyloarthritis Accessed October 2017.

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SOURCE Novartis Pharmaceuticals Corporation

 

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