. EMA CHMP positive opinion in non-radiographic axial spondyloarthritis (nr-axSpA) paves way for fourth indication in Europe, and is based on Phase III PREVENT data1

?If approved, Cosentyx would become the first fully-human IL-17A inhibitor indicated for patients in Europe with nr-axSpA

?There are approximately 1.7 million patients with nr-axSpA in the top five EU countries and US, which forms part of the axial spondyloarthritis (axSpA) disease spectrum2

?Cosentyx is backed by five years of clinical data supporting long-term safety and efficacy across ankylosing spondylitis (AS), psoriatic arthritis (PsA) and moderate-to-severe plaque psoriasis (PsO)3-6

Basel, March 27, 2020 — Novartis, a leader in rheumatology and immuno-dermatology, today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx® (secukinumab) for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA).

“Non-radiographic axial spondyloarthritis is part of the axSpA spectrum and is a painful and debilitating disease for which there are limited treatment options available,” said Eric Hughes, Global Development Unit Head, Immunology, Hepatology & Dermatology at Novartis. “This positive opinion marks another step forward in our commitment to reimagine medicine in axSpA and help patients realize relief from the burdensome symptoms of their disease earlier.”

The positive CHMP opinion of Cosentyx for nr-axSpA is based on efficacy and safety outcomes from the PREVENT Phase III study, which included 555 adults with active nr-axSpA with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence in adults who have responded inadequately to nonsteroidal anti-inflammatory drugs (NSAIDs). Cosentyx met the primary endpoint, achieving statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-naïve individuals at Week 161.

About axSpA
AxSpA is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain6,7. The axSpA spectrum includes AS, in which joint damage is generally visible on x-ray, and nr-axSpA, in which joint damage is not visible on x-ray6,7. Both parts of the disease spectrum have a comparable symptom burden, including nocturnal waking caused by pain, spinal pain, morning stiffness, fatigue and functional disability8. If left untreated, axSpA impairs activity, leads to lost work time and has a significant impact on quality of life, including family relationships8.

About Cosentyx
Cosentyx is the first and only fully-human biologic that directly inhibits IL-17A, a cornerstone cytokine involved in the inflammation and development of PsO, PsA and AS9-11.

Cosentyx is backed by robust clinical evidence, including five-year data across three indications of PsO, PsA and AS, as well as data from real world evidence3-5. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across axSpA, PsA and psoriatic disease, with more than 300,000 patients treated worldwide with Cosentyx since launch12.

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 “CHMP positive opinion,” etc. etc..

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References
1. Novartis data on file. September 2019
2. DRG Epidemiology Database - Axial Spondyloarthritis: Disease Landscape & Forecast. August 2019 [Internet]. Available from: https://decisionresourcesgroup.com/report/716950-biopharma-axial-spondyloarthritis-landscape-forecast/?. [Last accessed: November 2019].
3. Baraliakos X et al. Long-term Evaluation of Secukinumab in Ankylosing Spondylitis: 5 Year Efficacy and Safety Results from a Phase 3 Trial. Presented as a late-breaking abstract at the American College of Rheumatology Annual Meeting, 2018.
4. Bissonnette R, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. J Eur Acad Dermatol Venereol 2018;32:1507–1514.
5. Mease PJ, et al. Secukinumab provides sustained improvements in the signs and symptoms of psoriatic arthritis: Final 5-year results from the Phase 3 FUTURE 1 study. ACR Open Rheumatol 2020; 2(1):18–25.
6. Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.
7. Rudwaleit M, van der Heijde D, Landewé R, et al. The development of Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum Dis. 2009;68(6):777-783.
8. Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661-1670.
9. Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012;167:717–724.
10. Sieper J, et al. The IL-23–IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol 2019; 15:747–757.
11. Brembilla NC, Senra L, Boehncke W-H. The IL-17 Family of Cytokines in Psoriasis: IL-17A and Beyond. Front. Immunol. 2018;9:1682. doi: 10.3389/fimmu.2018.01682
12. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; May 2019

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