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Psoriasis News

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  • New prescribing information to include data demonstrating Cosentyx® (secukinumab) slows progression of joint structural damage associated with psoriatic arthritis (PsA) at Week 24(1)
  • PsA can lead to reduced mobility and irreversible joint damage if left untreated(2,3)
  • PsA affects an estimated 2 million people in the US and is characterized by joint pain and stiffness(3)

EAST HANOVER, N.J., June 19, 2018 /PRNewswire/ -- Novartis announced today that the US 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

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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

Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018.

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

National Psoriasis Foundation. Media Kit. Available at: https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Last accessed May 2018.

Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; February. 2018.

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

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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