Jun 03, 2026
  • Clinically meaningful, statistically significant efficacy achieved in primary and all secondary endpoints, including reduced steroid use; safety consistent with established Cosentyx profile1,2
  • Polymyalgia rheumatica (PMR) is an inflammatory rheumatic disease primarily affecting people over 50; extended steroid use associated with poor outcomes with limited advanced treatments3-7
  • Data have been submitted for health authority review in US, EU and Japan; additional country filings to follow throughout 2026

East Hanover, June 3, 2026 – Novartis presented today new Cosentyx® (secukinumab) data in polymyalgia rheumatica (PMR) demonstrating a statistically significant, clinically meaningful difference in sustained remission rates vs placebo and significant steroid sparing8. Published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress, Phase III REPLENISH data showed that the effect of Cosentyx treatment was sustained through week 52 in this investigational use8.

“PMR is an inflammatory rheumatic disease, characterized by disabling pain and stiffness in shoulders and pelvic girdle. There is an unmet need for a treatment that keeps symptoms under control over time with fewer relapses —while also reducing reliance on steroids,” said Prof Christian Dejaco, Director, Dept of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. “I am encouraged by the REPLENISH trial results which showed that Cosentyx, with its known safety profile, can reduce flares in the longer term while lowering patients’ steroid exposure.”

All primary and secondary endpoints of the REPLENISH trial were met across both Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 528. No new safety signals were identified in PMR patients receiving Cosentyx8.

"The publication of the REPLENISH data in the New England Journal of Medicine reflects the importance of these findings for patients with polymyalgia rheumatica (PMR), a disease with very limited advanced treatment options,” said Prof John Stone, MD, MPH, Professor of Medicine, Harvard Medical School, Massachusetts General Hospital, Boston, global principal investigator for the REPLENISH trial and lead author of the New England Journal of Medicine article. “The Phase III results showed a higher proportion of PMR patients achieved sustained remission with Cosentyx and further support IL-17A inhibition as a promising therapeutic approach in this disease.”

“Today’s results demonstrate that Cosentyx fills an unmet need by providing relief and renewed hope for people living with polymyalgia rheumatica (PMR) through improvement in disease control while reducing steroid use,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “We look forward to working with health authorities globally to expand the use of Cosentyx supported by the new REPLENISH data.”

Key efficacy results at week 528

Endpoint

Cosentyx 300mg

Cosentyx 150mg

Placebo

Sustained remission

41.2%*

40.6%*

20.4%

Mean adjusted annual cumulative glucocorticoid dose

1604 mg*

1683 mg#

2093 mg

* P-value < 0.001; adjusted for multiple testing

# P-value = 0.0015; adjusted for multiple testing

Novartis has submitted Cosentyx for polymyalgia rheumatica for health authority review in the US, EU and Japan. Regulatory submissions in additional countries are expected to follow throughout 2026.

About Cosentyx

Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS)9-11. Cosentyx is also approved for use in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and juvenile AS9-16.

About REPLENISH trial

The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 5217.

About polymyalgia rheumatica (PMR)

Polymyalgia rheumatica (PMR) is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips3. Relapses are frequent, affecting up to 40% of patients in the first year5, and long-term steroid use, the standard of care, carries significant risks including osteoporosis and diabetes18. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse5,19,20.

About Novartis Immunology

At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

What is the most important information I should know about COSENTYX?

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections

COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections while taking COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have died from these infections.

  • Your doctor should check you for TB before starting treatment with COSENTYX.
  • If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
  • Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection.

Before starting COSENTYX, tell your doctor if you:

  • are being treated for an infection
  • have an infection that does not go away or that keeps coming back
  • have TB or have been in close contact with someone with TB
  • have or have had Hepatitis B
  • think you have an infection or have symptoms of an infection such as:
  • fevers, sweats, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in your phlegm
  • weight loss
  • warm, red, or painful skin or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

What are the possible side effects of COSENTYX?

COSENTYX may cause serious side effects, including:

Serious allergic reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).

If you have a severe allergic reaction, do not give another injection of COSENTYX.

Inflammatory bowel disease

New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you get any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.

These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

Before using COSENTYX, tell your doctor if you:

  • have any of the conditions or symptoms listed above for infections.
  • have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  • are allergic to latex. The removable needle cap on the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains latex.
  • have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
  • have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
  • are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
  • are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

INDICATIONS

COSENTYX® (secukinumab) is a prescription medicine used to treat:

  • people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
  • adults and children 2 years of age and older with active psoriatic arthritis (PsA)
  • adults and children 12 years of age and older with active ankylosing spondylitis (AS)
  • adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
  • children 4 years of age and older with active enthesitis-related arthritis (ERA)
  • adults and children 12 years of age and older with moderate to severe hidradenitis suppurativa (HS)

Please see full Prescribing Information.

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,” “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 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 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; 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 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

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at www.novartis.us and connect with us on LinkedIn US, X/Twitter US and Instagram US.

References

  1. Stone J, et al [abstract]. IVW 2026
  2. Sun R, et al. Dermatol Ther (Heidelb). 2024;14(3):729-743;
  3. Espígol-Frigolé G, et al. Lancet. 2023;402(10411):1459–72.
  4. Gabriel SE, et al. Arthritis Rheum. 1997;40(10):1873–8.
  5. Floris A, et al. Clin Rheumatol. 2022;41(1):19-31
  6. Kevzara US PI. Available at: Kevzara Label (fda) Accessed: 20 Jan 2025
  7. Kevzara: EPAR - Product Information. Available at: Kevzara. INN-sarilumab. Accessed: 20 Jan 2025
  8. Dejaco C, et al. Oral Presentation #OP0116. EULAR 2026
  9. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: Cosentyx, INN-secukinumab [Last accessed: May 2026].
  10. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724.
  11. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last accessed: May 2026].
  12. Novartis Cosentyx receives FDA approval for treatment of children and adolescents with moderate to severe plaque psoriasis [Press release]. Available at:  https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-moderate-severe-plaque-psoriasis [Last accessed: May 2026].
  13. Novartis Cosentyx receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: May 2026].
  14. Novartis Cosentyx receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: May 2026].
  15. Novartis Cosentyx® receives FDA approval for pediatric patients aged 12+ with moderate to severe hidradenitis suppurativa. [Press release]. Available at:https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-pediatric-patients-aged-12-moderate-severe-hidradenitis-suppurativa [Last accessed: May 2026].
  16. Cosentyx. Prescribing information. Novartis Pharmaceuticals Corp.
  17. ClinicalTrials.gov. NCT05767034.[Last accessed: May2026]
  18. Mazzantini M, et al. J Rheumatol. 2012 Mar;39(3):552-7.
  19. Hutchings A, et al. Arthritis Rheum. 2007;57(5):803–9
  20. Mackie S.L, et al. Rheumatol Adv Pract. 2025 Dec 2;10(1):rkaf140. doi: 10.1093/rap/rkaf140

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