Novartis secures new approval in China for Cosentyx® (secukinumab) in pediatric psoriasis

• China National Medical Products Administration (NMPA) approval reinforces that Cosentyx^® (secukinumab) is safe and effective for children and adults with psoriasis

• Moderate-to-severe plaque psoriasis affects more than 350,000 children worldwide¹, with the physical and psychological burden disrupting important formative years²

• Cosentyx is a proven treatment, supported by long-term five-year sustained efficacy and safety data across several inflammatory conditions^3-5 and with more than 500,000 patients treated worldwide since launch⁶

• Approval in China for pediatric psoriasis combined with recent filings in the United States and Europe for juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA) further supports plans to expand Cosentyx to 10 indications over the next 10 years

Basel, August 17, 2021 –  Novartis today announced that the China National Medical Products Administration (NMPA) has further approved Cosentyx^® (secukinumab) for the treatment of moderate-to-severe plaque psoriasis in pediatric patients (six years and older with a body weight ≥50 kg) who are candidates for systemic therapy or phototherapy, making it the only interleukin inhibitor approved in China for these patients. Cosentyx is already approved in China for the treatment of moderate-to-severe plaque psoriasis in adults and adult ankylosing spondylitis. The approval is based on two Phase III international studies in pediatric patients aged 6 to < 18 years old, which showed that Cosentyx was as safe in children and adolescents as when used in adults^7,8.

“Psoriasis goes beyond skin symptoms. If left untreated it can become a source of embarrassment, affecting a young person’s self-esteem. The approval in China of Cosentyx means we are able to help even more children and adults around the world live their lives to the fullest, by providing them with a safe and effective therapy they can trust,” said Todd Fox, Novartis Global Medical Franchise, Head of Immunology, Hepatology and Dermatology. “With further US and European filings for childhood arthritic conditions, we have taken another step in our ambition to expand Cosentyx to 10 indications over the next 10 years as part of our commitment to immuno-dermatology and rheumatology.”

This approval in China follows recent approval of Cosentyx in the United States and Europe for the treatment of moderate-to-severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy.

Novartis is committed to making Cosentyx available to young patients who may benefit from the therapy and has recently filed for US and European regulatory approval for Cosentyx as a potential treatment in juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), two subtypes of juvenile idiopathic arthritis (JIA). Currently, there are very limited approved treatment options for JIA, and only a minority of patients go on to achieve and maintain an inactive disease state.

Cosentyx is backed by more than 14 years of clinical experience and long-term five-year clinical data across three indications of psoriasis, psoriatic arthritis (PsA) and axial spondyloarthritis (AS), as well as real-world evidence^3-5. These data strengthen the unique position of Cosentyx as a rapid and long-lasting comprehensive treatment across AS, PsA and psoriatic disease, with more than 500,000 patients treated worldwide with Cosentyx since launch⁶.

About psoriasis
Psoriasis is a chronic, inflammatory disease that affects more than 125 million people worldwide⁹, potentially impacting up to 350,000 children¹. One-third of psoriasis cases begin in childhood, and of these, the onset is most common during adolescence².

About Cosentyx^® (secukinumab)
Cosentyx is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), a cornerstone cytokine involved in the inflammation and development of moderate-to-severe plaque psoriasis, psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)^4,10,11. Cosentyx is the only biologic with proven efficacy in all six key manifestations of PsA^4,12,13.

This pediatric psoriasis approval in China is for 150 mg Cosentyx given by injection every four weeks for children with a body weight of at least 50 kg. After initial counseling and proper training in the injection technique, Cosentyx can be given by a child’s parent or carer at home. Cosentyx is also approved in China for treating adults with moderate-to-severe plaque psoriasis or ankylosing spondylitis.

Disclaimer
This media update 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,” “may,” “could,” “would,” “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 media update, 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 media update 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 and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity 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 media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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References
1.  Paller AS SR, Cloutier M, et al. Prevalence of Psoriasis in Children and Adolescents in the United States: A Claims-Based Analysis. J Drugs Dermatol. 2018;1:187-194.
2.  Menter A, Cordoro KM, Davis DMR, et al. Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management and treatment of psoriasis in pediatric patients. J Am Acad Dermatol. 2020;82:161-201.
3.  Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. 2018;32:1507-1514.
4.  Mease PJ, Kavanaugh A, Reimold A, 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;2:18-25.
5.  Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open. 2019;5:e001005.
6.  Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2021.
7.  Magnolo N, Kingo K, Laquer V, et al. Secukinumab treatment demonstrated high efficacy and safety in pediatric patients with moderate to severe plaque psoriasis: 52-week results from a randomized trial. Presented at AAD VMX 2021, Virtual Congress. 23-25 April 2021. Poster 26860.
8.  Bodemer C, Kaszuba A, Kingo K, et al. Secukinumab efficacy and safety profile in pediatric patients with severe chronic plaque psoriasis up to one year. Presented at AAD VMX 2021, Virtual Congress. 23-25 April 2021. Poster
9.  National Psoriasis Foundation. The impact of psoriasis. Available from: https://www.psoriasis.org/psoriasis-statistics/ [Last accessed: August 2021].
10.  Sieper J, Poddubnyy D and Miossec P. The IL-23-IL-17 pathway as a therapeutic target in axial spondyloarthritis. Nat Rev Rheumatol. 2019;15:747-757.
11.  Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.
12.  Baraliakos X, Gossec L, Pournara E, et al. Secukinumab in patients with psoriatic arthritis and axial manifestations: results from the double-blind, randomised, phase 3 MAXIMISE trial. Ann Rheum Dis. 2020.
13.  Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: August 2021].

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