Novartis receives approval for Cosentyx® label update in Europe to include dosing flexibility in ankylosing spondylitis

• New Cosentyx® (secukinumab) label to include 300 mg up-titration option is informed by results from the Phase III MEASURE 3 study[1]
   
• Approval provides clinicians with greater choice for their patients, based on clinical response to treatment[1]
   
• News follows recent announcement of submission to EMA for new indication for non-radiographic axial spondyloarthritis (nr-axSpA), potentially providing patients with a treatment that addresses the complete axSpA disease spectrum [2]

• Cosentyx is an established brand supported by 5-year sustained efficacy and safety data across psoriatic arthritis, ankylosing spondylitis and psoriasis , with over 250,000 patients treated worldwide[3]-[15] 

Basel, October 24, 2019 – Novartis, a leader in rheumatology and immuno-dermatology, announced today that the European Commission (EC) has approved a label update for the up-titration of Cosentyx (secukinumab) to 300 mg for patients with active ankylosing spondylitis (AS).

The approval is based on data from MEASURE 3, a three-year study that explored the tolerability and efficacy of Cosentyx in patients with AS[1]. Response rates were greater in the 300 mg dose group, particularly among patients with previous anti-TNF exposure, compared with the recommended 150 mg dose.  The safety profile was consistent with previous studies[1].

“This approval gives rheumatologists more flexibility to ensure their patients are able to achieve the best response to treatment,” said Sam Khalil, Global Head of Medical Affairs Immunology, Hepatology and Dermatology at Novartis. “It further encourages our ongoing efforts to reimagine care to ensure all patients are able to experience full relief from the signs and symptoms of AS.”

About axSpA
Axial spondyloarthritis (axSpA) is a spectrum of long-term inflammatory disease characterized by chronic inflammatory back pain[16]. The axSpA disease spectrum includes ankylosing spondylitis (AS), in which joint damage is visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint damage is not visible on x-ray[16]. Both parts of the disease spectrum have a comparable symptom burden, including nocturnal pain, fatigue, morning stiffness and functional disability[17]. If left untreated, axSpA can impair activity, lead to lost work time, and have a significant impact on quality of life[17].

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 psoriatic arthritis (PsA), psoriasis (PsO), and ankylosing spondylitis (AS)[18],[19].

Cosentyx is backed by robust clinical evidence, including 5-year data across PsO, PsA and AS, as well as data from real world evidence[3]-[15]. 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 250,000 patients treated worldwide with Cosentyx since its launcj[20].

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,” “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 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 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 more than 750 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at www.novartis.com.

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Novartis Global External Communications
E-mail: media.relations@novartis.com

Antonio Ligi Novartis Global External Communications +41 61 324 1374 (direct) antonio.ligi@novartis.com   Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.com

Friedrich von Heyl Novartis Global Pharma Communications +41 61 324 8984 (direct) +41 79 749 0286 (mobile) friedrich.vonheyl@novartis.com

References
[1]             ClinicalTrials.gov. 16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients (MEASURE 3). Available from: https://clinicaltrials.gov/ct2/show/NCT02008916. Last accessed: October 2019.
[2]             Novartis press release. Novartis Cosentyx^® positive 16-week PREVENT results advance potential new indication for patients with axial spondyloarthritis. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis. Last accessed: October 2019.
[3]             ClinicalTrials.gov. Search of: secukinumab, recruiting, not yet recruiting, active, not recruiting, completed, enrolling by invitation studies. Listed results on ClinicalTrials.gov [online]. Available from: https://clinicaltrials.gov/ct2/results?term=secukinumab&Search=Apply&recrs=b&recrs=a&recrs=f&recrs=d&recrs=e&age_v=&gndr=&type=&rslt= [Last accessed: October 2019].
[4]             ClinicalTrials.gov. Comparison of Secukinumab versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab (ARROW). NCT03553823. Available from: https://clinicaltrials.gov/ct2/show/NCT03553823 [Last accessed: October 2019].
[5]             Langley RG, et al. Secukinumab in plaque psoriasis—results of two phase 3 trials. N Engl J Med 2014;371:326–338.
[6]             Bagel J, et al. Secukinumab is Superior to Ustekinumab in Clearing Skin in Patients with Moderate to Severe Plaque Psoriasis (16-Week CLARITY Results). Dermatol Ther 2018;8:571–579.
[7]             ClinicalTrials.gov. Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as compared to GP2017 (Adalimumab Biosimilar) (SURPASS). NCT03259074. Available from: https://www.clinicaltrials.gov/ct2/show/NCT03259074 [Last accessed: October 2019].
[8]             Blauvelt A, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol 2017;76:60–69.
[9]             Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as eposter P2223 at 26th EADV Congress 2017. 13th October 2017.
[10]           Mease PJ, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5 Year Efficacy and Safety Results from a Phase 3 Trial. Abstract presented at the American College of Rheumatology Annual Meeting, 2018.
[11]           MEASURE 2. Novartis data on file.
[12]           Holdsworth E et al. Real world physician satisfaction with secukinumab in Psoriatic Arthritis and Ankylosing Spondylitis in Europe. Presented at EULAR 2019.
[13]           Michelsen B et al. Remission and drug retention rates of secukinumab in 1549 patients with psoriatic arthritis treated in routine care – pooled data from the observational EuroSpA Research Collaboration Network. Presented at EULAR 2019.
[14]           Michelsen B et al. Pooled 6-month treatment outcomes and drug retention rates in 1556 patients with axial spondyloarthritis treated with secukinumab in routine clinical practice in 12 European Countries in the EuroSpA Research Collaboration. Presented at EULAR 2019.
[15]           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.
[16]           Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017 Oct; 23(7): 383–391.
[17]           Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis and nonradiographic axial spondyloarthritis in the US-based Corrona Registry. Arthritis Care Res (Hoboken). 2018;70(11):1661-1670. 
[18]           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: October 2019.
[19]           Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167:717–724.
[20]           Novartis data on file. September 2019.

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